Expandable support structure for delivery through a working channel

ABSTRACT

Methods, systems, and devices for providing treatment to a target site are described. The system may include a guide assembly, an expandable support device coupled with the distal end of the guide assembly, and an operative member disposed on the expandable support device. The expandable support device may be configured to transition between a collapsed and expanded configuration. The expandable support device may be supported by one or more flexible supports aligned in parallel with an axis about which the expandable support device collapses and/or multiple splines arranged in a pattern configured to promote transitioning of the expandable support device between an expanded and collapsed configuration. The guide assembly may be configured to provide torque to the expandable support device. The operative member can include multiple electrodes arranged in parallel to the axis about which the expandable support device collapses.

CROSS REFERENCES

This application is a continuation of PCT/US2012/052326, filed Aug. 24,2012, entitled, “SYSTEMS, DEVICES, AND METHODS FOR TREATMENT OF LUMINALTISSUE,” which claims priority to U.S. provisional patent applicationNo. 61/527,554, titled “DEVICES AND METHODS FOR TREATMENT OF LUMINALTISSUE,” filed Aug. 25, 2011, each of which are incorporated byreference in their entirety for all purposes. This application is alsorelated to U.S. patent application No. 14/______, filed Feb. 25, 2014,entitled “EXPANDABLE SUPPORT STRUCTURE AND OPERATIVE ELEMENT FORDELIVERY THROUGH A WORKING CHANNEL;” U.S. patent application No.14/______, filed Feb. 25, 2014, entitled, “TRANSMITTING TORQUE TO ANOPERATIVE ELEMENT THROUGH A WORKING CHANNEL;” U.S. patent applicationNo. 14/______, filed Feb. 25, 2014, entitled “TRANSMITTING TORQUE WITH AHANDLE TO AN OPERATIVE ELEMENT THROUGH A WORKING CHANNEL;” U.S. patentapplication No. 14/______, filed Feb. 25, 2014, entitled, “FLEXIBLECIRCUIT FOR DELIVERY THROUGH A WORKING CHANNEL;” and U.S. patentapplication No. 14/______, filed Feb. 25, 2014, entitled, “EXPANDABLESUPPORT STRUCTURE FOR DELIVERY THROUGH A WORKING CHANNEL,” each of whichare incorporated by reference in their entirety for all purposes.

BACKGROUND

Various devices and techniques exist for providing therapy in the body.A common approach to administering treatment or performing diagnosticsat a tissue site in the body involves delivering an instrument to thesite at a distal end of an elongate catheter or endoscope. A problemexists, however, in that many instruments and devices do not fit withinthe catheter or endoscope. Currently, some devices may be limited in usebecause the treatment surface of the device is too large for delivery tothe site through a catheter or endoscope.

The delivery of many existing devices to a treatment site through theuse of a catheter or endoscope can also be hindered by the location ofthe treatment site within the body. In some cases, for example, thedevice needs to be able to navigate a tortuous path or small diameterbody lumens to reach a treatment site. Some known devices lack theability to bend along tortuous delivery paths

Another problem may exist with treating a target site significantlylarger than the delivery pathway through which the device must pass. Inorder to treat a large target site, a device with a large treatmentsurface is often desired. However, if the treatment surface is toolarge, it may not be possible to deliver the device through narrowlumens. If the treatment surface is reduced to fit within the catheteror endoscope, it may provide too small a surface area for efficient andefficacious delivery of treatment to the relatively large target site.

There may thus be a need for systems, devices and methods that mayovercome the above and/or other disadvantages of known systems andmethods.

SUMMARY

Methods, systems, and devices are described for providing treatment to atarget site, such as a site within a body lumen. Systems may include anexpandable support device that may be coupled with a distal end of aguide assembly. An operative member may be disposed on the expandablesupport device such that moving the expandable support device to thetarget site using the guide assembly delivers the operative member tothe target site. The guide assembly may be utilized to transmit torqueand/or to rotate to the expandable support device and/or the operativemember.

The expandable support member may include a solid body of elastomericmaterial. The elastomeric material may be flexible so that it maytransition between a folded, or collapsed configuration and a planar, orexpanded, configuration. One or more flexible supports may be coupledwith the elastomeric body such that the flexible supports are eachaligned parallel to a central axis of the elastomeric body. The flexiblesupports may be made from at least a highly elastic, such as springsteel, or a superelastic material, such as nitinol, and may be arrangedin a single central axis configuration, a wishbone configuration, or atrident configuration.

The expandable support member may include a solid support member madefrom at least a highly elastic or superelastic material that issupported by multiple splines located within the perimeter of the solidsupport member. The multiple splines may be separated by voids so as tocreate a pattern of splines having a width and spacing that promotestransitioning of the solid support member between a collapsedconfiguration and an expanded configuration. The splines may be arrangedin a pattern wherein a spline arranged to substantially overlap acentral axis of the solid support member has splines extending away fromthe central spline in both directions towards a distal end of the solidsupport member.

The operative member may include a flexible circuit capable of bendingwith the expandable support device upon which it is disposed. Theflexible circuit may include multiple electrodes aligned in parallel toone another. The electrodes may also be aligned in parallel to an axisabout which the flexible circuit collapses from a planar configurationto a folded configuration so that the electrodes do not substantiallyimpede the transition between an expanded configuration and a collapsedconfiguration. The flexible circuit may include a first bus at one endof the parallel electrodes and a second bus at the opposite end of theelectrodes. The electrodes may be coupled with the first and second busin an alternating pattern.

The guide assembly that may be used to move the expandable supportdevice may include a first shaft portion and a second shaft portionseparated by a break. Transmission lines may extend through both thefirst shaft and the second shaft. The break between the first shaft andthe second shaft may allow the first shaft to rotate independently ofthe second shaft. The first shaft may be configured such that rotationof the first shaft transmits torque and/or rotation to the expandablesupport device.

In some embodiments, an expandable support device may be configured fordelivering an operative member through a working channel to a targettreatment area. The expandable support device may include an elastomericbody that is configured to support the operative member and promoteexpansion of the expandable support device between a collapsedconfiguration and an expanded configuration. The elastomeric body mayinclude a proximal portion that is configured for coupling theelastomeric body with a guide assembly, a distal portion that isopposite the proximal portion, and a central axis that extends betweenthe distal portion and the proximal portion of the elastomeric body. Theexpandable support device may also include one or more supports that arecoupled with the elastomeric body. The one or more supports may bealigned parallel to the central axis of the elastomeric body. At leastone of the supports may include at least a highly elastic orsuperelastic material.

The expandable support device may include two supports that are arrangedin a wishbone configuration. The expandable support may include threesupports that are arranged in a trident configuration. The expandablesupport device may have a single support that extends along at least aportion of the central axis of the elastomeric body. The expandablesupport device may have one or more supports that are configured as atleast linear supports or longitudinal supports. The expandable supportdevice may include supports that are made from a superelastic material.The superelastic material may include nitinol. The expandable supportmay include supports that are made from highly elastic material. Thehighly elastic material may include spring steel. One or more of thesupports coupled with the elastomeric body may include polyimide One ormore of the supports including polyimide may be disposed at a peripheryof the elastomeric body.

The expandable support device may also include an operative memberdisposed on the elastomeric body. The operative member disposed on theelastomeric body may be an ablation device. The expandable supportdevice may also include protective padding that encompasses the distalend of each of the supports. The protective padding may includesilicone.

The proximal portion of the elastomeric body may be tapered in adirection away from the distal end of the elastomeric support. Theelastomeric body may also be configured to facilitate movement of theexpandable support device into the working channel. The elastomeric bodymay include silicone. The elastomeric body may be transparent. Theelastomeric body may be a molded elastomeric body. The working channelmay include at least a portion of an endoscope or a catheter. Thesupports may be coupled with the elastomeric body using a siliconeadhesive. One side of the proximal portion of the elastomeric body mayinclude a marking or a texturing. The marking or texturing mayfacilitate identifying on which side of the elastomeric body theoperative member is positioned.

Some embodiments include a system for delivering treatment to a targettreatment that may include an expandable support device. The expandablesupport device may be configured for delivering an operative memberthrough a working channel to a target treatment area. The expandablesupport device may include an elastomeric body, one or more supportscoupled with the elastomeric body, and an operative member disposed onthe elastomeric body. The elastomeric body may be configured to supportan operative member and promote expansion of the expandable supportdevice between a collapsed configuration and an expanded configuration.The elastomeric body may include a proximal portion configured forcoupling the elastomeric body with a guide assembly, a distal portionopposite the proximal portion, and a central axis extending between thedistal portion and the proximal portion of the elastomeric body. The oneor more supports coupled with the elastomeric body may be alignedparallel to the central axis of the elastomeric body. At least one ofthe supports may include at least a highly elastic or superelasticmaterial.

The system may also include a guide assembly. The guide assembly mayinclude a guide shaft and a coupling mechanism that is configured tocouple the expandable support device to the guide shaft. The system mayalso include a working channel. The working channel may be configured toreceive the expandable support device and the guide assembly. Theoperative member of the system may include an ablation device. Theworking channel of the system may include at least a portion of anendoscope or a catheter.

Some embodiments include a method of delivering an expandable supportdevice to a target treatment area that may a step of providing anexpandable support device configured for delivering an operative memberthrough a working channel to a target treatment area. The method mayalso include a step of inserting the expandable support device into afirst end of the working channel and a step of moving the expandablesupport device through the working channel until the expandable supportdevice passes out of a second end of the working channel. The expandablesupport device may include an elastomeric body and one or more supportscoupled with the elastomeric body. The elastomeric body may beconfigured to support an operative member and promote expansion of theexpandable support device between a collapsed configuration and anexpanded configuration. The elastomeric body may include a proximalportion configured for coupling the elastomeric body with a guideassembly, a distal portion opposite the proximal portion, and a centralaxis extending between the distal portion and the proximal portion ofthe elastomeric body. The one or more supports may be aligned parallelto the central axis of the elastomeric body. At least one of thesupports may include at least a highly elastic or superelastic material.The method may also include positioning the expandable support deviceinto a collapsed position prior to inserting the expandable supportdevice into the working channel.

Some embodiments include a guide assembly for delivering and positioningan operative member through a working channel to a target treatment areathat may include one or more transmission lines, a first shaft enclosingat least a first portion of the one or more transmission lines, and asecond shaft enclosing at least a second portion of the transmissionlines. The transmission lines may operatively connect the operativemember to a power source. The first shaft may be configured fortransmitting torque to the operative member. The first shaft and thesecond shaft may be configured to allow the first shaft to rotateindependently of the second shaft.

The first shaft may include a flexible shaft. The flexible shaft mayinclude stainless steel. The flexible shaft may include two or morelayers, with each layer including two or more stainless steel wireswound around a common axis. The flexible shaft may be configured tocouple with an expandable support device configured to deliver theoperative member through a working channel to a target treatment area.

The one or more transmission lines may be coupled with the first shaftat a distal end of the first shaft and decoupled from the first shaft ata proximal end of the first shaft. The guide assembly may also include aprotection element. The protection element may be coupled with the firstshaft and extend over a portion of the second shaft. The guide assemblymay also include a control element. The control element may be coupledwith the first shaft and configured to transmit rotational motion to thefirst shaft. The control element may be coupled with the first shaft forapproximately one to one rotational movement between the control elementand the first shaft. The control element may be coupled with the firstshaft by a crimp tube fixed at one end of the control. A control elementand a protection element may be integrated with each other as oneelement in some cases.

The first shaft may include a rigid section at the proximal end of thefirst shaft. The rigid section of the first shaft may be configured tobe inserted into the working channel. The rigid section of the firstshaft may have a length of at least 2 cm in some embodiments. The firstshaft may also include a flexible section that is positioned between therigid section and the operative member. The second shaft may be coupledwith the power source. The second shaft may also be rotationally fixedrelative to the power source. The one or more transmission lines mayinclude electrical wires. The first shaft and the second shaft may beconfigured to axially move the operative member. The first shaft may beconfigured to axially move the operative member. The first shaft may belocated between the operative member and the second shaft. The secondshaft may be located between the first shaft and the power source.

The guide assembly may also include a handle that is coupled with thefirst shaft. The guide assembly may also include an introducer. Theintroducer may include a conical section, a cylindrical section, and achannel extending through the conical section and the cylindricalsection. The first shaft may extend through the channel. The cylindricalsection may be configured to insert into the working channel. The guideassembly may include a docking member. The docking member may include afirst end, a second end, and a channel extending through the dockingmember. The first end of the docking member may be configured to couplewith the introducer. The docking member may be configured at least tocouple with or be integrated with at least a control element or aprotection element.

Some embodiments include a system for delivering treatment to a targettreatment that may include a guide assembly, an expandable supportdevice, and an operative member. The guide assembly may be provided fordelivering and positioning the operative member through a workingchannel to a target treatment area. The guide assembly may include oneor more transmission lines, a first shaft enclosing at least a firstportion of the one or more transmission lines, a second shaft enclosingat least a second portion of the transmission lines.

The transmission lines may operatively connect the operative member to apower source. The first shaft may be configured for transmitting torqueto the operative member. The first shaft and the second shaft may beconfigured to allow the first shaft to rotate independently of thesecond shaft. The expandable support device may be configured to deliverthe operative member through the working channel to the target treatmentarea. The expandable support device may be coupled with a distal end ofthe guide assembly. The operative member may be coupled with theexpandable support device.

The expandable support device of the system may include an elastomericbody configured to support the operative member. The elastomeric bodymay include a proximal portion configured for coupling the elastomericbody with the guide assembly, a distal portion opposite the proximalportion, and a central axis extending between the distal portion and theproximal portion.

The system may also include one or more supports coupled with theelastomeric body and aligned parallel to the central axis of theelastomeric body. At least one of the supports may include at least ahighly elastic or superelastic material. The operative member of thesystem may be coupled with the transmission lines.

Some embodiments include a method of utilizing a guide assembly fordelivering an operative member to a target treatment that may include astep of providing a system. The system may include a guide assembly fordelivering and positioning the operative member through a workingchannel to the target treatment area, an expandable support deviceconfigured to deliver the operative member through the working channelto the target treatment area and coupled with a distal end of the guideassembly, and an operative member coupled with the expandable supportdevice. The guide assembly may include one or more transmission linesfor operatively connecting the operative member to a power source, afirst shaft enclosing at least a first portion of the one or moretransmission lines, and a second shaft enclosing at least a secondportion of the transmission lines. The first shaft may be configured fortransmitting torque to the operative member. The first shaft and thesecond shaft may be configured to allow the first shaft to rotateindependently of the second shaft. The method may also include a step ofinserting the expandable support device into a first end of the workingchannel, and a step of moving the expandable support device through theworking channel utilizing the guide assembly until the expandablesupport device passes out of a second end of the working channel.

The method may also include a step of positioning the expandable supportdevice into a collapsed position prior to inserting the expandablesupport device into the working channel. The method may also include astep of rotating the first shaft to provide torque to the operativemember.

Some embodiments include a guide assembly configured for positioning anoperative member through a working channel and to a target treatmentarea that may include one or more transmission lines for operativelyconnecting the operative member to a power source. The guide assemblymay also include a flexible shaft enclosing at least a portion of theone or more power transmission lines. The flexible shaft may beconfigured for transmitting torque to the operative member. The guideassembly may also include a handle element. The handle element mayinclude a body and a channel extending through the body. The flexibleshaft may pass through the channel and the handle element may beconfigured such that the flexible shaft may move through the channel.

The guide assembly may also include a rigid shaft coupled with a firstend of the handle element. The rigid shaft may be configured such thatthe flexible shaft may move through the rigid shaft. The rigid shaft mayhave a length of at least 2 cm in some embodiments. The rigid sectionmay be configured to be inserted into the working channel.

The guide assembly may also include a power source side shaft. The powersource side shaft may be configured to allow the flexible shaft torotate independently of the power source side shaft. The power sourceside shaft may be located between the flexible shaft and the powersource. The handle element may extend over a portion of the power sourceside shaft. The flexible shaft may include two or more layers. Eachlayer may include two or more stainless steel wires wound around acommon axis. The flexible shaft may be configured to couple with anexpandable support device configured to deliver the operative memberthrough a working channel to a target treatment area. The power sourceside shaft may be coupled with the power source. The power source sideshaft may also be rotationally fixed relative to the power source. Theone or more transmission lines may include electrical wires.

The guide assembly may also include a locking mechanism that is coupledwith the handle element. The locking mechanism may be secured to theflexible shaft inside the channel of the handle. The locking mechanismmay be configured to move along an axis of the handle element to adjusta length of the flexible shaft extending out of the handle element. Thelocking mechanism may move along the axis of the handle element when inan unlocked position and may be fixed to the handle element when in alocked position. The handle element may be configured to slide along theflexible shaft and the locking mechanism may be configured to lock thehandle element at a position along the flexible shaft.

The guide assembly may also include a protection element coupled withthe flexible shaft. The protection element may extend over a portion ofthe second shaft. The protection element may be coupled with theflexible shaft at a position between the handle element and the powersource side shaft. The flexible shaft and the power source side shaftmay be configured to axially move the operative member.

Some embodiments include a method of delivering an operative member to atarget treatment area that may include a step of providing a system. Thesystem may include a guide assembly. The guide assembly may include oneor more transmission lines for operatively connecting an operativemember to a power source, a flexible shaft enclosing at least a portionof the one or more power transmission lines, and a handle element. Theflexible shaft may be configured for transmitting torque to theoperative member. The handle element may include a body and a channelextending through the body. The flexible shaft may pass through thechannel. The handle element may be configured such that the flexibleshaft moves through the channel. The system may also include anoperative member coupled with a distal end of the flexible shaft. Themethod may also include a step of inserting the operative member into afirst end of a working channel, a step of moving the operative memberthrough the working channel until the operative member passes out of thesecond end of the working channel, and a step of rotating the handleelement to transmit torque to the operative member. The method mayfurther include a step of positioning the operative member into acollapsed position prior to inserting the operative member into theworking channel.

Some embodiments include a system for delivering treatment to a targetarea that may include a guide assembly. The guide assembly may includeone or more transmission lines for operatively connecting an operativemember to a power source, a flexible shaft enclosing at least a portionof the one or more power transmission lines, and a handle element. Theflexible shaft may be configured for transmitting torque to theoperative member. The handle element may include a body and a channelextending through the body. The flexible shaft may pass through thechannel. The handle element may be configured such that the flexibleshaft may move through the channel. The system may also include anexpandable support device coupled with a distal end of the flexibleshaft and an operative member disposed on the expandable support device.The operative member of the system may include a flexible circuit.

Some embodiments include an ablation device that may be configured fordelivery through a working channel to a target treatment area. Theablation device may include a flexible circuit configured to transitionbetween a collapsed configuration and an expanded configuration. Theflexible circuit may include multiple parallel electrodes configured tocollapse around an axis parallel to the multiple parallel electrodes.

The flexible circuit may also include a first bus coupled with a firstsubset of the multiple parallel electrodes and a second bus coupled witha second subset of the multiple parallel electrodes. The first bus andthe second bus may be at least partially covered by one or moreinsulation layers. The insulation layers may be configured to impede thefirst and second bus from ablating the target treatment area. The one ormore insulation layers may include polyimide.

The first bus may be located at a first end of the multiple parallelelectrodes. The second bus may be located at a second end of themultiple parallel electrodes. The multiple parallel electrodes may bearranged in a row. The first bus and the second bus may be coupled withalternating electrodes in the row. The first bus and the second bus mayeach be arched. The first bus and the second bus may each includemultiple arches. The end of each arch in the multiple arches may becoupled with a single electrode. The first bus may be configured tocouple with a positive terminal. The second bus may be configured tocouple with a negative terminal or a ground terminal.

The ablation device may also include an elastomeric body having a firstsurface and a second surface opposite the first surface. The flexiblecircuit may be disposed on the first surface of the elastomeric body. Insome embodiments, the multiple parallel electrodes may eachsubstantially extend to a distal end of the elastomeric body.

The elastomeric body having the flexible circuit disposed thereon may beconfigured to collapse around an axis parallel to the multiple parallelelectrodes when disposed within a working channel and expand to asubstantially flat orientation when the elastomeric body emerges fromthe working channel.

The ablation device may also include a first bus and a second busdisposed on the second surface of the elastomeric body. The first busmay be coupled with a first subset of the multiple electrodes and thesecond bus may be coupled with a second subset of the multipleelectrodes. The elastomeric body may include one or more vias throughwhich the first subset of electrodes couple to the first bus and one ormore vias through which the second subset of electrodes couple to thesecond bus. The first bus and the second bus may be alignedsubstantially perpendicular to the multiple parallel electrodes. Thefirst bus and the second bus may include copper. The first bus and thesecond bus may have a hash pattern with multiple void spaces. The firstand second bus may be located between a first end of the multipleparallel electrodes and a second end of the multiple parallelelectrodes.

Some embodiments include a system for delivering treatment to a targettreatment that may include a guide assembly having a central axis, anelastomeric body coupled with the guide assembly, and a flexible circuitdisposed on the elastomeric body. The flexible circuit may includemultiple parallel electrodes configured to collapse around an axisparallel to the multiple parallel electrodes and parallel to the centralaxis of the guide assembly.

The system may also include one or more supports coupled with theelastomeric body and aligned parallel to the central axis of the guideassembly. At least one of the supports may include a superelasticmaterial. The system may also include a working channel configured toreceive the guide assembly, the elastomeric body, and the flexiblecircuit disposed on the elastomeric body. The elastomeric body and theflexible circuit may be in a collapsed configuration when disposedinside of the working channel. The elastomeric body and the flexiblecircuit may expand to a substantially flat orientation when theelastomeric body is outside the working channel.

Some embodiments include a method of delivering an ablation device to atarget treatment area that may include a step of providing an ablationdevice. The ablation device may include a flexible circuit configured totransition between a collapsed configuration and an expandedconfiguration. The flexible circuit may include multiple parallelelectrodes configured to collapse around an axis parallel to themultiple parallel electrodes. The method may also include a stepinserting the ablation device into a first end of a working channel, anda step of moving the ablation device through the working channel untilthe ablation device passes out of a second end of the working channel.The method may also include a step of positioning the flexible circuitinto a collapsed configuration prior to inserting the ablation deviceinto the working channel.

Some embodiments include an expandable support device configured fordelivery through a working channel and to a target treatment area thatmay include a solid support member having a perimeter and highly elasticor superelastic properties. The expandable support device may alsoinclude multiple splines formed in a pattern interior to the perimeterof the solid support member. Multiple voids may be located betweenadjacent splines. The width and a spacing of the multiple splines may beconfigured to promote expansion of the support member between acollapsed configuration and an expanded configuration providing asupport surface.

The solid support member may include a proximal end, a distal end, and acentral axis extending from the proximal end to the distal end. Thepattern of the multiple splines may include a central axis splinesubstantially overlapping the central axis of the solid support member,a first subset of splines extending from the central axis spline towardsa first lateral peripheral edge of the solid support member, and asecond subset of splines extending from the central axis spline towardsa second lateral peripheral edge of the solid support member oppositethe first lateral peripheral edge.

The first subset of splines may be arranged in parallel to one another.The second subset of splines may be arranged in parallel to one another.The first subset of splines and the second subset of splines may extendfrom the central axis spline at an angle such that the first and secondsubsets of splines extend from the central axis spline towards thedistal end of the solid support member. The first subset of spines andthe second subset of spines may extend from the central axis spline atan angle in the range of from greater than 0 degrees to 90 degrees. Thefirst subset of splines and the second subset of splines may extend fromthe central axis spline at an angle of about 45 degrees. The firstsubset of splines and the second subset of splines may have a thicknessless than a thickness of the central axis spline.

The solid support member may include of a metal having shape memoryproperties. The support surface may define a curved surface in theexpanded configuration. The support surface may define a substantiallyplanar surface in the expanded configuration. The predetermined shapemay correspond to a tissue surface at a treatment site in a patient. Thesolid support member may have a thickness of about 0.003 inch in someembodiments.

The pattern of the multiple splines may include multiple equally spacedvertical splines interconnected by horizontal splines. The expandablesupport may also include an operative member supported by the multiplesplines. The operative member may be coupled with the multiple splineswith an elastomeric adhesive. The operative member may include aflexible circuit. The flexible circuit may include multiple electrodespatterned to mirror the pattern of the multiple splines. The operativemember may extend across an entire width of the solid support member.The solid support member may include a rounded distal edge. The solidsupport member may include a tapered proximal edge for promotingretraction of the device into the working channel.

Some embodiments include a system for delivering treatment to a targetarea that may include a solid support member having a perimeter and atleast a highly elastic or superelastic properties, multiple splinesformed in a pattern interior to the perimeter of the solid supportmember, and multiple voids between adjacent splines. The width and aspacing of the multiple splines may be configured to promote expansionof the support member between a collapsed configuration and an expandedconfiguration providing a support surface. The system may also includean operative member disposed on the solid support member.

The solid support member may have a first surface and a second surfaceopposite the first surface. The multiple splines may be disposed on thefirst surface and the operative member may be disposed on the secondsurface. The operative member may include a flexible circuit.

Some embodiments include a method of delivering an expandable supportdevice to a target treatment area that may include a step of providingan expandable support device. The expandable support device may includea solid support member having a perimeter and at least highly elastic orsuperelastic properties. The expandable support device may also includemultiple splines formed in a pattern interior to the perimeter of thesolid support member and multiple voids between adjacent splines. Awidth and a spacing of the multiple splines may be configured to promoteexpansion of the support member between a collapsed configuration and anexpanded configuration providing a support surface. The method may alsoinclude a step of inserting the expandable support device into a firstend of a working channel, and a step of moving the expandable supportdevice through the working channel until the expandable support devicepasses out of a second end of the working channel. The method may alsoinclude positioning the expandable support device into a collapsedconfiguration prior to inserting the expandable support device into theworking channel.

Some embodiments include an expandable support device configured fordelivery through a working channel and to a target treatment area thatmay include an expandable support member configured for supporting anoperative member. The expandable support member may include multiplesplines having a width and a spacing selected to promote expansion ofthe support member between a collapsed configuration and an expandedconfiguration. A portion of the support member may define a surface inthe expanded configuration.

The multiple splines may include a central axis spline, a first subsetof splines extending away from the central axis in a first direction,and a second subset of splines extending away from the central axisspline in a direction opposite the first direction. The first subset ofsplines may be arranged in parallel to one another. The second subset ofsplines may be arranged in parallel to one another. The first subset ofsplines and the second subset of splines may extend away from thecentral axis spline at an angle such that the first and second subsetsof splines extend from the central axis spline towards a distal end ofthe central axis spline. The first subset of splines and the secondsubset of splines may extend away from the central axis spline at anangle in the range of from greater than 0 degrees to 90 degrees. Thefirst subset of splines and the second subset of splines may extend awayfrom the central axis spline at an angle of about 45 degrees. The firstsubset of splines and the second subset of splines may have a thicknessless than a thickness of the central axis spline. The multiple splinesmay include nitinol. The multiple splines may include a central axisspline, multiple secondary splines arranged in parallel to the centralaxis spline, equally space apart from one another, and on either side ofthe central axis spline, and multiple interconnecting splines arrangedtransverse to the secondary splines and interconnecting the secondarysplines.

Some embodiments include a system for providing treatment to a targettreatment area that may include an expandable support member configuredfor supporting an operative member. The expandable support member mayinclude multiple splines having a width and a spacing selected topromote expansion of the expandable support member between a collapsedconfiguration and an expanded configuration. A portion of the expandablesupport member may define a surface in the expanded configuration. Thesystem may also include a solid elastomeric body. The expandable supportmember may be disposed on the solid elastomeric body within a perimeterof the solid elastomeric body. The system may also include an operativemember coupled with the solid elastomeric body.

The multiple splines may include a central axis spline, a first subsetof splines extending away from the central axis in a first direction,and a second subset of splines extending away from the central axisspline in a direction opposite the first direction. The first subset ofsplines may be arranged in parallel to one another. The second subset ofsplines may be arranged in parallel to one another. The first subset ofsplines and the second subset of splines may extend away from thecentral axis spline at an angle such that the first and second subsetsof splines extend from the central axis spline towards a distal end ofthe central axis spline. The first subset of splines and the secondsubset of splines may extend away from the central axis spline at anangle of about 45 degrees. The operative member may be coupled with thesolid elastomeric body with an elastomeric adhesive.

The operative member may be a flexible circuit. The flexible circuit mayinclude multiple electrodes patterned to mirror the multiple splines.The operative member may extend across an entire width of the solidelastomeric body.

Some embodiments include a method of delivering an expandable supportdevice to a target treatment area that may include a step of providingan expandable support device configured for delivery through a workingchannel to a target treatment area. The expandable support device mayinclude an expandable support member configured for supporting anoperative member. The expandable support member may include multiplesplines having a width and a spacing selected to promote expansion ofthe support member between a collapsed configuration and an expandedconfiguration. A portion of the support member may define a surface inthe expanded configuration. The method may also include a step ofinserting the expandable support device into a first end of the workingchannel, and a step of moving the expandable support device through theworking channel until the expandable support device passes out of asecond end of the working channel. The method may also include a step ofpositioning the expandable support device into a collapsed positionprior to inserting the expandable support device into the workingchannel.

The foregoing has outlined rather broadly the features and technicaladvantages of examples according to the disclosure in order that thedetailed description that follows may be better understood. Additionalfeatures and advantages will be described hereinafter. The conceptionand specific examples disclosed may be readily utilized as a basis formodifying or designing other structures for carrying out the samepurposes of the present disclosure. Such equivalent constructions do notdepart from the spirit and scope of the appended claims. Features whichare believed to be characteristic of the concepts disclosed herein, bothas to their organization and method of operation, together withassociated advantages will be better understood from the followingdescription when considered in connection with the accompanying figures.Each of the figures is provided for the purpose of illustration anddescription only, and not as a definition of the limits of the claims.

BRIEF DESCRIPTION OF THE DRAWING

A further understanding of the nature and advantages of the embodimentsmay be realized by reference to the following drawings. In the appendedfigures, similar components or features may have the same referencelabel. Further, various components of the same type may be distinguishedby following the reference label by a dash and a second label thatdistinguishes among the similar components. If only the first referencelabel is used in the specification, the description is applicable to anyone of the similar components having the same first reference labelirrespective of the second reference label.

FIG. 1A is a schematic diagram of a system for delivering treatment to atarget treatment area including components configured according tovarious embodiments.

FIG. 1B is schematic diagram of one specific embodiment of the systemshown in FIG. 1A.

FIG. 2 is a cross-sectional view of an expandable support device in aworking channel according to various embodiments

FIGS. 3A-3C are cross-sectional views of a collapsed and expandedexpandable support device positioned proximate a target treatment areaaccording to various embodiments.

FIG. 4 is a simplified line drawing illustrating an expandable supportdevice in an expanded configuration according to various embodiments.

FIGS. 5A-5F are perspective views of various stages of an expandablesupport device being passed through a working channel according tovarious embodiments.

FIG. 6A is plan view of a flexible support coupled with an expandablesupport device according to various embodiments.

FIG. 6B is a plan view of two flexible supports coupled with anexpandable support device according to various embodiments.

FIG. 6C is a plan view of three flexible supports coupled with anexpandable support device according to various embodiments.

FIG. 7 is a side view of a flexible support coupled with an expandablesupport device according to various embodiments.

FIG. 8 is a side view of a flexible support coupled with an expandablesupport device according to various embodiments.

FIGS. 9A-9C are cross sectional views of varying numbers of flexiblesupports coupled with an expandable support device according to variousembodiments.

FIGS. 10A-10C are cross-sectional views of varying numbers of flexiblesupports coupled with an expandable support device according to variousembodiments.

FIG. 11A is a plan view of a patterned solid substrate according tovarious embodiments.

FIG. 11B is a plan view of a patterned solid substrate according tovarious embodiments.

FIGS. 12A-12B are plan views of a patterned solid substrate according tovarious embodiments.

FIGS. 13A-13L are plan views and side views of patterned solidsubstrates according to various embodiments.

FIGS. 14A-14B are plan views of an electrode structure for an operativemember according to various embodiments.

FIGS. 15A-15B are plan views of an electrode structure for an operativemember according to various embodiments.

FIG. 16A is a schematic view of an electrode structure for an operativemember according to various embodiments.

FIG. 16B is a cross-sectional view of the electrode structure shown inFIG. 16B according to various embodiments.

FIGS. 17A-17D are plan views of an operative member according to variousembodiments.

FIGS. 18A-18B are perspective views of a guide assembly according tovarious embodiments.

FIGS. 19A-19B are perspective views of a guide assembly according tovarious embodiments.

FIG. 20 is a perspective view of a handle element for use with a guideassembly according to various embodiments.

FIG. 21 is a perspective view of a handle element for use with a guideassembly according to various embodiments.

FIG. 22 is a perspective view of a distal plug according to variousembodiments.

FIG. 23 is a perspective view of a torque member according to variousembodiments.

FIGS. 24A-24B are perspective and cross-section views, respectively, ofa torque member according to various embodiments.

FIGS. 25A-25B are perspective views of an introducer according tovarious embodiments.

FIGS. 26A-26B are perspective views of an introducer according tovarious embodiments.

FIGS. 27A-27F are cross-sectional views of a method for making anoperative member and coupling it with a flexible support according tovarious embodiments.

FIGS. 28A-28E are cross-section views of a method for making a patternedsolid support and coupling it to an operative member according tovarious embodiments.

FIG. 29 is a flow diagram illustrating a method for using a therapysystem according to various embodiments.

FIG. 30 is a flow diagram illustrating a method for delivering anexpandable support device to a target treatment area according tovarious embodiments.

FIG. 31 is a flow diagram illustrating a method for utilizing a guideassembly for delivering an operative member to a target treatmentaccording to various embodiments.

FIG. 32 is a flow diagram illustrating a method for delivering anoperative member to a target treatment area according to variousembodiments.

FIG. 33 is a flow diagram illustrating a method for delivering anablation device to a target treatment area according to variousembodiments.

FIG. 34 is a flow diagram illustrating a method for delivering anexpandable support device to a target treatment area according tovarious embodiments.

FIG. 35 is a flow diagram illustrating a method for delivering anexpandable support device to a target treatment area according tovarious embodiments.

DETAILED DESCRIPTION

Methods, systems, and devices are described for providing treatment to atarget site, such as a site within a body lumen. Systems may include anexpandable support device that may be coupled with a distal end of aguide assembly. An operative member can be disposed on the expandablesupport device such that moving the expandable support device to thetarget site using the guide assembly delivers the operative member tothe target site. The guide assembly may be utilized to transmit torqueand/or to rotate to the expandable support device and/or the operativemember.

The expandable support member can include a solid body of elastomericmaterial. The elastomeric material can be flexible so that it maytransition between a folded, or collapsed configuration and a planar, orexpanded, configuration. One or more flexible supports can be coupledwith the elastomeric body such that the flexible supports are eachaligned parallel to a central axis of the elastomeric body. The flexiblesupports can be made from at least a highly elastic, such as springsteel, or a superelastic material, such as nitinol, and can be arrangedin a single central axis configuration, a wishbone configuration, atrident configuration, or other configurations, including open andclosed configurations.

The expandable support member can include a solid support member madefrom a highly elastic or superelastic material that is supported bymultiple splines located within the perimeter of the solid supportmember. The multiple splines can be separated by voids so as to create apattern of splines having a width and spacing that promotestransitioning of the solid support member between a collapsedconfiguration and an expanded configuration. The splines can be arrangedin a pattern wherein a spline arranged to substantially overlap acentral axis of the solid support member has splines extending away fromthe central spline in both directions towards a distal end of the solidsupport member.

The operative member can include a flexible circuit capable of bendingwith the expandable support device upon which it is disposed. Theflexible circuit can include multiple electrodes aligned in parallel toone another. The electrodes can also be aligned in parallel to an axisabout which the flexible circuit collapses from a planar configurationto a folded configuration so that the electrodes do not substantiallyimpede the transition between an expanded configuration and a collapsedconfiguration. The flexible circuit can include a first bus at one endof the parallel electrodes and a second bus at the opposite end of theelectrodes. The electrodes can be coupled with the first and second busin an alternating pattern.

The guide assembly that can be used to move the expandable supportdevice can include a first shaft portion and a second shaft portionseparated by a break. Transmission lines can extend through both thefirst shaft and the second shaft. The break between the first shaft andthe second shaft can allow the first shaft to rotate independently ofthe second shaft. The first shaft can be configured such that rotationof the first shaft transmits torque and/or rotation to the expandablesupport device.

With reference to FIG. 1A, a general system 100 for delivering treatmentto a target treatment area is shown in accordance with variousembodiments. The system 100 may be designed for providing treatment to atarget area inside of a body, such as the wall of an organ or lumens inthe gastrointestinal tract, for example. The system 100 can include apower source 105, a guide assembly 110, a working channel 115, and/or anexpandable support device 120. The expandable support device 120 maygenerally be configured to support an operative member that is used tosupply therapy to the target treatment area. The system 100 may operateby positioning at least a portion of the working channel 115 inside abody and passing the expandable support device 120 through the workingchannel 115 using the guide assembly 110 such that the expandablesupport device 120 may be delivered to a target treatment area insidethe body. The power source 105 may then be used to supply power to anoperative member disposed on the expandable support device 120 so thattherapy can be applied to the target treatment area.

The expandable support device 120 can be a self-expanding device capableof transitioning between a collapsed configuration and an expandedconfiguration with little or no use of supplementary expansionmechanisms. The collapsed configuration may be generally used when theexpandable support device 120 is inside of the working channel 115.

When the expandable support device 120 emerges from the working channel115, the expandable support device 120 may self-expand, such as bytransitioning from a curved orientation (i.e., the collapsedconfiguration) to a substantially planar orientation (i.e., the expandedconfiguration).

The expandable support device 120 can be configured to support anoperative member. In some embodiments, the operative member is atherapeutic or diagnostic instrument, such as an ablation element thatcan provide ablative energy to the target treatment area. Some operativemembers may be designed so that they make direct contact with a targettreatment area, including pressing of the operative member against thetarget site.

The expandable support device 120 may be coupled with the guide assembly110 such that the guide assembly 110 can be used to maneuver theexpandable support device 120 through the working channel 115 and at thetarget treatment area. The guide assembly 110 may include a proximal end130 and a distal end 135, with the proximal end 130 configured to becoupled with the power source 105 and the distal end 135 configured tobe coupled with the expandable support device 120. In some embodiments,the guide assembly 110 includes a break 140 that allows the distalportion of the guide assembly 110 to rotate independently of theproximal portion of the guide assembly 110. The break 140 may typicallybe located outside of the working channel 115 and proximate the powersource 105. Rotating the distal portion of the guide assembly 110 canprovide torque to the expandable support device 120 and allow for bettermovement and control of the expandable support device 120 at the targettreatment area.

The working channel 115 may include a proximal end 145 and a distal end150, and can be configured such that the expandable support device 120can be inserted into the working channel 115 at the proximal end 145 andguided through the length of the working channel 115 using the guideassembly 110 until it emerges from the distal end 150 of the workingchannel 115. In some embodiments, the expandable support device 120 ispositioned in a collapsed configuration prior to being inserted into theworking channel 115 so that the expandable support device 120 fitsinside of the working channel 115 and remains in a collapsedconfiguration as the expandable support device 120 moves through theworking channel 115. The working channel 115 can be oriented such thatthe distal end 150 is proximate the target treatment area. In suchconfigurations, the expandable support device 120 may be located near orat the target treatment area when it emerges from the distal end 150 ofthe working channel 115.

The power source 105 can generally be provided to provide power to theoperative member that may be coupled with the expandable support device120 and/or the operative member disposed theron. In some embodiments,power is provided from the power source 105 to the expandable supportdevice 120 via one or more transmission lines extending between thepower source 105 and the expandable support device 120 and housed withinthe guide assembly 110.

FIG. 1B illustrates a system 100-a that may be an example of the system100 shown in FIG. 1A according to various embodiments. The system 100-amay include a generator 105-a, a guide assembly 110-a that may include afirst shaft 112 and a second shaft 114, an endoscope 115-a, anexpandable support device 120-a, a flexible support 155 extending alongthe central axis of the expandable support device 120-a, and/or anoperative member 160 supported by the expandable support device 120-a.

The expandable support device 120-a may include a solid elastomeric bodyon which the operative member 160 is supported. The expandable supportdevice 120-a may thus be a flexible material capable of being curved orfolded. The expandable support device 120-a may generally have a paddleshape, including a rounded distal end. The expandable support device120-a may taper at the proximal end and couple to the guide assembly110-a.

Disposed on one surface of the expandable support device 120-a may be anoperative member 160 that may be configured to provide treatment to thetarget treatment area. As shown in FIG. 1B, the operative member 160 maybe a series of electrodes aligned in parallel to one another and thatextend from the proximal end of the expandable support device 120-a tothe distal end of the expandable support device 120-a. The electrodesmay be interlaced, with approximately half of the electrodes extendingfrom a first bus located at the proximal end of the expandable supportdevice 120-a and approximately half of the electrodes extending from asecond bus located at the distal end of the expandable support device120-a. The first bus or the second bus may be connected to a positiveterminal and the other of the first bus or the second bus may beconnected to a negative or ground terminal to thereby provide a bipolarelectrode configuration. When connected to the generator 105-a, theelectrodes can provide ablative energy to the target treatment area.

Also included on the expandable support device 120-a may be a flexiblesupport 155, which can be made from nitinol so that the flexible support155 exhibits superelastic properties. The flexible support 155 maygenerally extend from the proximal end of the expandable support device120-a to the distal end of the expandable support device 120-a along acentral axis of the flexible support device 120-a. The flexible support155 can be located on a surface of the expandable support device 120-aopposite the surface on which the operative member 160 may be disposed.The flexible support 155 may give the expandable support device 120-a adesired amount of structure so that the flexible support device 120-acan be transported through the guide assembly 110 without crumpling uponitself. The flexible support 155 can also provide apposition force whenthe expandable support device 120-a is deflected against a targettreatment area, such as tissue.

The expandable support device 120-a may be coupled with the guideassembly 110, which is split into a first shaft 112 and a second shaft114. A common set of transmission wires may extend from the generator105-a to the expandable support device 120-a and through both the firstshaft 112 and the second shaft 114. The break 140 shown in FIG. 1A mayserve as the dividing point between the first shaft 112 and the secondshaft 114, and may allow the first shaft 112 to rotate independently ofthe second shaft 114. A protection element 165 may be coupled with thefirst shaft 112 and extend over a portion of the second shaft 114 tothereby cover the break 140 and protect the transmission lines runningthrough the guide assembly 110. Because the protection element 165 maybe coupled with the first shaft 112, the protection element 165 can alsoserves as a torque handle that can be rotated to rotate the first shaft112 and provide torque to the expandable support device 120-a. The firstshaft 112 may be flexible and can be made from stainless steel, such ascoiled stainless steel wires.

The endoscope 115-a may be provided for accessing a target treatmentarea within a body. In some embodiments, the endoscope 115-a includesone working channels and the expandable support device 120-a and theguide assembly 110 can be passed through the one working channel in theendoscope 115-a to reach the target treatment area. The endoscope 115-acan include partitions to create multiple channels, where at least oneof the channels may be a working channel, and the expandable supportdevice 120-a and the guide assembly 110 can be passed through one of thechannels in the endoscope 115-a to reach the target treatment area. Insome embodiments, the endoscope 115-a is passed into the body throughthe mouth and provides access to the esophagus.

FIGS. 2-5 provide further detail on the expandable support device 120illustrated in FIG. 1 in accordance with various embodiments. Withreference to FIG. 2, the expandable support device 120-b may be coupledwith the guide assembly 110-b. Although not shown in FIG. 2, theexpandable support device 120-b may carry an operative member fordelivering therapy to a target treatment area.

Expandable support device 120-b is shown in FIG. 2 in a collapsedconfiguration within the working channel 115-b in accordance withvarious embodiments. Two additional channels 205 and 210 may beprovided, and the three channels 115-b, 205, 210 may be housed within anouter casing 215. While FIG. 2 shows the outer casing 215 having threechannels, the outer casing 215 may have fewer or more channels. Theadditional channels may be used for a variety of purposes, including forproviding suction, aspiration, illumination, magnification, and/ordelivery of other instruments to the target treatment area. In someembodiments, the outer casing 215 is an endoscope having one or morechannels within the endoscope. A typical endoscope arrangement may havethree channels, with one working channel provided for the expandablesupport device, one channel for a camera and the associated wiring, andone channel for a light source. It may be desirable to provide a workingchannel capable of receiving two or more devices, such as the expandablesupport device 120-b and a suction device. In some embodiments, theexpandable support device 120-b is removed when suction is activated.

One may appreciate that the term working channel may refer to a widevariety of channels used for providing instruments to target areas. Forexample, in a bronchoscope, a working channel may be referred to as abiopsy port. As will be described further herein, the expandable supportdevice 120 in accordance with various embodiments described herein maybe used with a variety of instruments depending on the medicalapplication.

With reference to FIG. 3A, the expandable support device 120-c is shownin a collapsed configuration in accordance with various embodiments. Theexpandable support device 120-c may be configured for transitioningbetween the collapsed configuration shown and an expanded configurationshown in FIG. 3B or FIG. 3C. The expandable support device 120-c may beconfigured for insertion into a working channel in the collapsedconfiguration. When the expandable support device 120-c is delivered outof an end of the working channel, it may transition to the expandedconfiguration. In the expanded configuration, at least one dimension ofthe expandable support device 120-c may have increased. When anoperative member is disposed on the expandable support device 120-c, theoperative member may also transition between an expanded configurationand a collapsed configuration. In various embodiments, the expandedconfiguration is significantly larger than the collapsed configurationand allows the expandable support device 120-c to contact a treatmentsurface 300. As will be described below, the expandable support device120-c itself does not necessarily increase in size. Rather, in variousrespects, “expansion” refers to the radial expansion, increase inthree-dimensional space, and/or opening of the device.

In various embodiments, the expandable support device 120-c isreleasably retained in the collapsed configuration by a working channel(not shown in FIG. 3A). One may appreciate from the description hereinthat the collapsed and expanded configuration may be reversed. Invarious embodiments, the expandable support device 120-c is configuredto self-collapse from an expanded configuration.

As shown, for example, in FIG. 3A, the expandable support device 120-cmay have a rounded or curved shape in the collapsed configuration. Theexemplary collapsed shape may generally conform to the inner wallsurface of a working channel. The outer surface of the expandablesupport device 120-c may generally remain in contact with the wall ofthe working channel along its entire surface. In some cases, theexpandable support device 120-c may be configured such that thecollapsed configuration results in different shapes. The expandablesupport device 120-c may tend to have a rounded shape without creases orsharp radiuses when it collapses. This can be due in part to theoperative member disposed on the expandable support device 120-cresisting bending. In some embodiments, the expandable support device120-c collapses into a U-shape.

It may be desirable to have a generally uniform radius in the collapsedconfiguration. It may be desirable for the whole collapsed expandablesupport device 120-c to expand against the inner wall surface of aworking channel. As would be understood by one of skill in the art, thismay maximize the chord length and enable the delivery of a largersurface in the working channel.

One may appreciate that the collapsed configuration size and shape maydepend on the particular application and instruments being used. Theouter casing 215 may be an endoscope having one or more workingchannels. A typical endoscope working channel may have a diameter ofabout 1 mm, about 2 mm, about 3 mm, about 5 mm, about 8 mm, or about 10mm. In various embodiments, the expandable support device 120-ccollapses to permit insertion through a working channel diameter ofabout 1.2 mm, about 1.7 mm, about 2.0 mm, about 2.6 mm, about 2.8 mm,about 3.7 mm, about 5.0 mm, or about 6.0 mm. Some endoscope workingchannels may have other diameters.

Although reference has been made to the outer casing 215 being anendoscope, one may appreciate that the expandable support device 120-cmay be used with a variety of delivery instruments including, but notlimited to, a catheter. Moreover, the expandable support device 120-cmay be delivered through various types of working channels, such ascatheter lumens, a cannula lumen, or a lumen in the body of a patient.The expandable support device 120-c may also be configured for use witha variety of other instruments as would be understood by one of skill inthe art. For example, the expandable support device 120-c may bedelivered using an introducer or other delivery device. The expandablesupport device 120-c may be held in a collapsed configuration with asheath, a fastener, or a similar device.

With reference to FIG. 3B, the expanded configuration of the expandablesupport device 120-c may have a substantially planar shape relative tothe collapsed configuration shape shown in FIG. 3A. The expandablesupport device 120-c may have an expanded configuration whereby asurface of the expanded support device 120-c on which the operativemember 160-a may be disposed has a generally flat shape with a minimal,laterally-curved bias. The expandable support device 120-c in theexpanded configuration may present an outwardly facing treatment surfacetowards a target treatment area 300. The expandable support device 120-cin the expanded configuration may have a planar treatment surface. Invarious embodiments, in the expanded configuration most, or all, of thetreatment surface is flat. In various embodiments, in the expandedconfiguration a central portion of the treatment surface is essentiallyflat and the outer regions are slightly curved.

With continuing reference to FIG. 3B, the operative member 160-a may bedisposed on the expandable support device 120-c. The expandable supportdevice 120-c may be attached to a distal end of a guide assembly 110-c.In an exemplary embodiment, the guide assembly 110-c is positionedwithin a working channel to guide the expandable support device 120-cthrough and out of the working channel. The guide assembly 110-c mayallow a user to manipulate the expandable support device 120-c from aproximal end of the guide assembly 110-c. The guide assembly 110-c mayallow the expandable support device 120-c to be pushed, pulled, androtated.

With reference to FIG. 3C, the expanded configuration of the expandablesupport device 120-c may have a curved shape. In some embodiments, thecurved shape of the expanded configuration is less curved than thecurved shape of the collapsed configuration shown in FIG. 3A. In otherwords, the radius of the expandable support device 120-c in the expandedconfiguration may begreater than the radius of the expandable supportdevice 120-c in the collapsed configuration. Expanded configurationshaving a curve as shown in FIG. 3C can be beneficial for providinguniform tissue contact against a curved surface, such as can be the casefor an esophagus.

With reference to FIG. 4, a simplified schematic view of an expandedsupport device 120-d in an expanded configuration is shown in accordancewith various embodiments. The shape of the expandable support device120-d in the expanded configuration may be planar. The expandablesupport device 120-d may define a surface with a slight curvature havinga radius “R”. The surface of the expandable support device 120-d mayhave a width “W”. As will be described below in additional detail, thewidth W of the expandable support device 120-d may be wider than adiameter of the working channel (W_(c)) from which it is deployed. Invarious embodiments, however, the radius R is at least an order ofmagnitude larger than W and W_(c). In various embodiments, the ratio R/Wis at least 2, at least 5, at least 10, or more than 100. In variousembodiments, the expandable support device 120-d in an expandedconfiguration defines a completely flat surface with no radius.

It may be desirable to provide an expandable support device 120-d thatdeploys a relatively large surface area. In other words, it may bedesirable to have an expandable support device 120-d in an expandedconfiguration that has a large width relative to the working channel.The ability of the expanded support device 120-d to expand from theworking channel may allow for a W/W_(c) ratio greater than 1. In variousembodiments, the ratio of W/W_(c) is at least 1. 5, at least 2, at least5, at least 10, or more than 100. In other embodiments, the ratio ofW/W_(c) may take on other values.

The general nature of delivery and deployment of the expandable supportdevice in accordance with various embodiments may now be described withreference to FIGS. 5A-5F, which are perspective views of an expandablesupport device 120-e entering a working channel 115-e at a first end andexiting a working channel 115-e at a second end opposite the first end.As shown in FIGS. 5A-5F, expandable support device 120-e may beconfigured to expand from the collapsed configuration in working channel115-e to an expanded configuration out of the working channel 115-e. InFIG. 5A and FIG. 5B, the expandable support device 120-e may be rolledor folded to accommodate delivery through a small diameter of theworking channel 115-e. In FIG. 5C and FIG. 5D, the expandable supportdevice 120-e may begin to exit the working channel 115-e. In FIG. 5C,only a distal end of the expandable support device 120-e may haveemerged from the working channel 115-e, and as a result, the expandablesupport device 120-e remains mostly in the collapsed configuration. InFIG. 5D, more of the expandable support device 120-e may have emergedfrom the working channel 115-e, and as a result, the expandable supportdevice 120-e may begin to transition from the collapsed configuration tothe expanded configuration. In FIG. 5E, the expandable support device120-e may fully emerge from the working channel 115-e and is thereforein the fully expanded configuration. In the expanded configuration shownin FIG. 5E, the expandable support device 120-e may be unfolded into agenerally planar surface shaped to contact a target area. Althoughreferred to as “expansion,” the surface of the expandable support device120-e may change shape during expansion but does not actually changesurface area. Rather, the expandable support device 120-e may open up ina wing-like fashion to present a larger surface area to a treatmentarea. As shown in FIG. 5E, for example, the expandable support device120-e in the expanded configuration better conforms to a treatment area.

In various embodiments, the collapsed configuration has a small contactsurface and the expandable support device is configured to expand toprovide a broad surface. In the case of treating a gastrointestinal (GI)tract, for example, the contact surface of the expandable support devicemay be significantly larger in the expanded configuration. This may bedue in part because the GI tract has a larger diameter than exemplaryworking channel. The larger radius of the GI tract wall may present arelatively flatter contact surface. However, a completely flatexpandable support device may have poor contact of the expandablesupport device with the comparatively rounded GI tract wall. In variousembodiments, the shape and dimensions of the expanded configuration areselected to conform to the treatment site, such as the inner lumen wall.For example, the expandable support device may have a deployedcurviplanar shape that corresponds to the radius of curvature of thetreatment area.

One of skill in the art may appreciate that the inner walls of many bodylumens may not be planar or perfectly round. Many body lumens are rough.Some body lumens include trabeculae or folds along the inner surface. Invarious embodiments, the expandable support device in an expandedconfiguration has a shape selected based on the wall surface to betreated. For example, the expandable support device in the expandedconfiguration may include waves or undulations. The expandable supportdevice in the expanded configuration may have a shape that matches theshape of the target surface. The expanded support device in an expandedconfiguration may have a flat shape to smooth out a rough or foldedtarget surface.

In various embodiments, expanded support device is configured to improveapposition in the expanded configuration. In various embodiments, theexpandable support device has sufficient rigidity in the expandedconfiguration to provide a contact force at the treatment site andachieve good apposition. In various embodiments, the expandable supportdevice in the expanded configuration has adequate rigidity to applypressure to the treatment surface, for example, to pressure vasculaturein the tissue for hemostasis.

In general, the expanded force is within a range to allow the expandablesupport device to be collapsed back into the working channel whileproviding sufficient expansion force for delivering treatment. In anexemplary embodiment, operative member disposed on the expandablesupport device comprises a malleable copper and a thin insulator. Assuch, the operative member tends to resist changing shape. Thus theexpansion force of expandable support device is sufficient to ensureself-expansion in view of the operative member resistance and otherenvironmental factors.

In various respects, the expansion force is selected to adjust a contactforce (also referred to as deflection force) of the expandable supportdevice with the treatment area surface. The expansion force may varydepending on the application. For example, a body lumen in thealimentary tract is typically stronger and able to withstand a greaterinternal force than a blood vessel. The expansion force may depend onthe treatment surface area required. For example, less force may benecessary for an expandable support device configured for deploying inan artery. The expansion force may also vary depending on the treatment.For example, a hemostasis device for the vasculature may require lessexpansion force than an ablation device for the esophagus. Other factorsthat can impact the contact force include the flexible support and theworking channel deflection.

In various embodiments, the expandable support device is dimensioned andconfigured to exert an expansion force (i.e., radial force) of at least5 GPa when it is in the collapsed configuration. In various embodiments,the expansion force is equal to or greater than the bending strength ofthe operative member disposed on the expandable support device. Invarious applications, it may be desirable to reduce the expansion forceto reduce the risk of injury to the vessel in which the expandablesupport device is to be deployed. A large expansion force, for example,may damage a blood vessel. In various embodiments, the expandablesupport device is configured to deploy gradually, or at selected timeintervals, rather than snap open. In various embodiments, the expandablesupport device is configured to exert a non-uniform expansion force. Forexample, the outer edges of the expandable support device may exert alower or higher expansion force. In various embodiments, when theexpandable support device is in the expanded configuration the expansionforce along its outer edge is at least 0.5 GPa, at least 5 GPa, at least25 GPa, or at least 40 GPa. Some embodiments may utilize other expansionforce values. The expandable support device may include features toreduce the risk of injury such as a curviplanar treatment surface androunded edges.

In various embodiments, the expandable support device is configured toapply sufficient force to smooth out the inner wall surface at thetreatment site. For example, the expandable support device can bepressed against the inner wall surface to unfold the folds in the wall.

One may appreciate from the description herein that the expandedconfiguration of the expandable support device plays a role in theparameters of the expandable support device's contact with the treatmentsite. If the expandable support device expands to a completely flatshape and is extremely rigid, the expandable support device may not makegood contact with a rounded surface. Likewise, if the expandable supportdevice in an expanded configuration has some flexibility, it may be ableto conform, to a degree, to the treatment surface. An expandable supportdevice with a rounded surface in an expanded configuration may be lessappropriate for contacting a generally flat treatment site. In someapplications, it may be desirable to achieve less than full contact ofthe expandable support member with the treatment site. The expandablesupport device may have an expanded configuration of a fixed shape andsize selected to provide more contact with larger diameter lumens andless contact with smaller diameters lumens, or vice versa. For example,the expanded configuration may have a small radius such that it achievesmore contact with a smaller lumen and allows for spot treatment of alarger lumen. This configuration may be appropriate for delivering moreenergy to differently sized body lumens using the same device.

In another example, the expanded support device in the expandedconfiguration may include several different treatment surfaces fordifferent parts of a body. In various embodiments, the treatment surfaceis on an underside of the expanded support device. In this manner, theexpanded support device may be deployed through a narrow aperture (e.g.,lower esophageal sphincter) to treat abnormal tissue on the other side(e.g., stomach lining). In one example, the treatment surface iscup-shaped, for example, to treat abnormal cervical tissue.

In various embodiments, expandable support device include a firsttreatment surface and at least another treatment surface. The anothertreatment surface may be substantially planar or another shape. Thetreatment surface and the another treatment surface may be contiguous.

In various embodiments, the expanded configuration of expandable supportdevice is adjustable. For example, a supplementary expansion device maybe provided to increase expansion—further flatten and unroll theexpandable support device—or decrease expansion. In various embodiments,the supplementary expansion device is an expandable member (e.g. aballoon) or an actuator. The expanded configuration may be adjustedmanually or automatically. The expanded configuration adjustment may bedetermined by a user with user controls or predetermined based on presetparameters.

With reference to FIG. 5F, the expandable support device 120-e has aparticular expanded shape in accordance with various embodiments. In theexpanded configuration, expandable support device 120-e may have bodyshaped like a paddle. The expandable support device 120-e may have aperimeter with generally parallel sides extending in a longitudinaldirection. The expandable support device 120-e may include an atraumaticdistal end 1105. The distal end 1105 of the expandable support device120-e may be rounded to avoid sharp edges and corners that allow theexpandable support device 120-e to be moved axially without riskinginadvertent perforation or injury of the treatment area. As used herein,the “axial” direction is the direction from the proximal end to thedistal end. In various embodiments, the distal end 1105 has a radius ofabout 0.25 inch. In various embodiments, the distal end 1105 has aradius of about 0.125 inch. The rounded distal end 1105 may meet theside edges at a smooth transition. Thus, at least an outward portion ofthe periphery of the expandable support device 120-e is rounded toreduce of injury or damage. The rounded distal end 1105 may also promotecollapsing and insertion of the expandable support device 120-e into theworking channel 115-e.

A proximal end 1110 of the expandable support device 120-e may betapered to promote withdrawal of the expandable support device 120-einto the working channel 115-e. In particular, the tapered proximal end1110 provides an angled contact surface for contacting the edges of theworking channel 115-e. As the expandable support device 120-e iswithdrawn into the working channel 115-e, the walls of the workingchannel 115-e may provide a folding force on the expandable supportdevice 120-e to cause the expandable support device 120-e to contract tothe collapsed configuration. This folding action is similar to a featherwithdrawn into a tube. As will be described below, the expandablesupport device 120-e may have a structure and configuration carefullyselected to promote and control the collapsing and expanding actions.The proximal end 1110 can also be configured for coupling to the guideshaft 110.

In some embodiments, one side of the expandable support device 120-e istextured or otherwise marked at the tapered proximal end 1110 toindicate on which side expandable support device 120-e the operativemember is disposed. Such texturing or marking can be useful when theexpandable support member 120-e is transparent and it becomes difficultfor a user to distinguish between the sides of the expandable supportdevice 120-e. The texturing and marking can also be on an operativemember disposed on the expandable support device 120-e.

One may appreciate from the description herein, however, that the shapeand configuration of the expandable support device 120-e may varydepending on the application. For example, the expandable support device120-e may have curved sides or a polygonal-shaped periphery. In variousembodiments, the expandable support device 120-e is substantiallyelliptical. The expandable support device 120-e may also have differentcross-sectional shapes when deployed.

In some embodiments, the expandable support device includes a solid bodyof elastomeric material. The solid body of elastomeric material can be amolded elastomeric body, including an elastomeric body molded in theshape of a paddle as described above. In some embodiments, theelastomeric material is silicone. The elastomeric body can betransparent, translucent, and/or opaque, for example. A solidelastomeric body can be a suitable material for the expandable supportbody because of its flexibility and resistance to plastic deformation.The elastomeric material can generally provide the expandable supportdevice with the ability to transition between a collapsed configurationand an expanded configuration, as a generally planar body of elastomericmaterial can be folded or curved through the application of externalforce, followed by returning to its planar configuration when theapplication of external force is removed. The solid elastomeric bodyused for the expandable support device can have a variety of thicknessesin accordance with various embodiments.

With reference to FIG. 6A, an expandable support device 120-g in theshape of a paddle and which can be made from a solid elastomeric body isprovided in accordance with various embodiments, and further includes aflexible support 155-a coupled with the expandable support device 120-g.The flexible support 155-a can be provided to add additional structuralsupport to the expandable support device 120-g and/or to provideapposition force when the expandable support device 120-g is deflectedagainst a target treatment area. Providing additional support to theexpandable support device 120-g can be useful when the expandablesupport device 120-g is made from a flexible material, such as anelastomeric material. Without a flexible support 155-a coupled with anexpandable support device 120-g made from a solid elastomeric body, theexpandable support device 120-g may run into problems when beingtransported through a working channel, such as folding over on itselfand creating obstructions within the working channel. When a flexiblesupport 155-a is provided, the expandable support device 120-g may havesuitable structure support so as to maintain the expandable supportdevice 120-g in the collapsed configuration while being transportedthrough a working channel.

As shown in FIG. 6A, the flexible support 155-a may extend from theproximal end 1110-a to the distal end 1105-a of the expandable supportdevice 120-g. In some embodiments, the flexible support 155-a overlapsand is aligned with a central axis extending between the proximal end1110-a and the distal end 1105-a of the expandable support device 120-g.

The flexible support 155-a may be made from a flexible material so thatit is capable of bending when the expandable support device 120-g isbeing passed through a non-linear working channel. In some embodiments,the flexible support 155-a is made from at least a highly elastic orsuperelastic material. The superelastic material can be nitinol, forexample. The highly elastic material can be spring steel, for example.

In FIG. 6A, the expandable support device 120-g may include a singleflexible support 155-a, and no further supports may be provided.However, other embodiments may include two or more flexible supports.With reference to FIG. 6B, the expandable support device 120-h includestwo flexible supports 155-b-1, 155-b-2 arranged in a “wishbone”configuration in accordance with various embodiments. In this wishboneconfiguration, the flexible supports 155-b-1, 155-b-2 may be arranged inparallel to the central axis of the expandable support device 120-h, butare located at the peripheral edges of the expandable support device120-h. With reference to FIG. 6C, the expandable support device 120-iincludes three flexible supports 155-c-1, 155-c-2, 155-c-3 arranged in a“trident” configuration in accordance with various embodiments. In thistrident configuration, the flexible supports 155-c-1, 155-c-3 may bearranged in parallel to the central axis and located at the peripheraledges of the expandable support device 120-i, while support 155-c-2 isaligned with and overlaps the central axis of the expandable supportdevice 120-i. As shown in FIGS. 7 and 8, the peripherally locatedflexible supports can include taper sections that follow the taper ofthe expandable support device at the proximal end. While FIGS. 6A-C showusing from one to three flexible supports, any number of flexiblesupports can be used. Additionally, the flexible supports can be linearor longitudinal supports. Other embodiments may utilize otherconfigurations, including open and/or closed configurations.

In some embodiments where more than one flexible support is provided,the flexible supports can be made from different materials. For example,in the trident configuration shown in FIG. 6C, the flexible support155-c-2 located along the central axis can be made from nitinol, whilethe peripherally located flexible supports 155-c-1, 155-c-3 can be madefrom a different material, such as polyimide. The thickness of eachflexible support can also be variable, such as when peripherally locatedflexible supports 155-c-1, 155-c-3 are thinner than the flexible support155-c-2 located along the central axis.

With reference to FIG. 6A, a protective padding 1245 can encompass thedistal tip of the flexible support 155-a. When multiple flexiblesupports are used, a protective padding can encompass some or all of theflexible supports. With reference to FIG. 6B, protective paddings1245-a-1 and 1245-a-2 encompass the distal tips of flexible supports155-b-1 and 155-b-2. With reference to FIG. 6C, protective paddings1245-b-1, 1245-b-2, 1245-b-3 encompass the distal tips of flexiblesupports 155-c-1, 155-c-2, 155-c-3. The protective padding can beprovided to prevent the distal tips of the flexible supports fromdamaging the target treatment area. In some embodiment, the protectivepadding comprises silicone layered above and below the distal tips.

In some embodiments, the flexible supports are configured as straightflexible supports, with no bends, curves, or the like. In other words,the flexible supports may be aligned generally in parallel to the guideassembly. With reference to FIGS. 7 and 8, some embodiments of theflexible support include one or more bends. As shown in FIG. 7, theflexible support 155-a-1 may beangled in a downward direction such thatthe expandable support device 120-g-1 coupled with the flexible support155-a-1 is also positioned at an angle. As shown in FIG. 8, the flexiblesupport 155-a-2 may include two approximately right angle bends so thatthe flexible support 155-a-2 has two parallel sections on differentplanes. The expandable support device 120-g-2 can be coupled with theportion of the flexible support 155-a-2 that is on different plane fromthe portion of the flexible support 155-a-2 extending out of a workingchannel. Other configurations are also possible. Generally speaking, thenon-linear flexible support can be provided to improve contact betweenthe operative member disposed thereon and the target treatment area.

Any manner of coupling the flexible supports to the expandable supportdevice can be used. In some embodiments, the flexible supports arecoupled the expandable support device using a silicone adhesive. Withreference to FIG. 9A, FIG. 9B, and/or FIG. 9C, the flexible supports155-d, 155-e-1, 155-e-2, 1554-1, 1554-2, 1554-3 can be coupled withtheir respective expandable support device 120-j, 120-k, 120-1 such thatthe flexible supports are positioned outside of their respectiveexpandable support device 120-j, 120-k, 120-1. With reference to FIG.10A, FIG. 10B, and/or FIG. 10C, the flexible supports 155-g, 155-h-1,155-h-2, 155-i-1, 155-i-2, 155-i-3 can be coupled with their respectiveexpandable support device 120-m, 120-n, 120-o such that they arepartially embedded within their respective expandable support device120-m, 120-n, 120-o. The expandable support devices 120-m, 120-n, and120-o can be overmolded with primer for adhesion to the respectiveflexible supports 155-g, 155-h-1, 155-h-2, 155-i-1, 155-i-2, 155-i-3.

In various embodiments, the expandable support device includes a solidsubstrate in which portions of the solid substrate are selectivelyremoved from the substrate to form a pattern of splines and voids. Thepattern formed in the solid substrate can be specifically designed tocontrol the bending or folding of the patterned solid substrate.Removing portions of the solid substrate can generally result in thesolid substrate having less strength and folding more easily. In otherwords, the pattern formed in the solid substrate can influence thebending strength or rigidity of the solid substrate. The pattern may beselected to provide different bending strength in localized regions ofthe patterned solid substrate. For example, the pattern may be selectedto provide greater rigidity along a central region and relatively lessbending rigidity along longitudinal outer edges. The resulting patternedsolid substrate can be self-expanding. An expansion force such as aballoon inflation force is generally not necessary to expand the solidsubstrate. In various embodiments, the solid support self-expands to apredetermined shape.

The selective removal of material and the specific pattern selected canadjust the expansion force of the solid substrate within a specificrange to optimize expansion while allowing collapsing back into acollapsed configuration. In some embodiments, the width and spacing ofthe splines formed by patterning impacts the ability of the solidsubstrate to transition between the collapsed and expandedconfiguration.

In some embodiments, the solid substrate begins as a plate of solidsubstrate material, after which the plate is shaped and patterned toprovide the final patterned solid substrate suitable for use as a partof the expandable support device. In some embodiments, the plate has auniform thickness in the range of from 0.002 to 0.004 inch. In variousembodiments, the plate has a variable thickness or is patterned to havea variable thickness (i.e., patterned to have splines of varyingthickness). The solid substrate may be thin such that the thickness isorders of magnitude smaller than the width and height.

The solid substrate patterned to include multiple splines and voids canbe used alone as the expandable substrate device, or can be used inconjunction with the solid elastomeric body described in greater detailabove. When the patterned substrate is used alone for the expandablesupport device, an operative member can be disposed directly on thepatterned substrate. When used in conjunction with the solid elastomericbody described above, the patterned substrate can be disposed on andcoupled with a surface of the solid elastomeric body.

In some embodiments, the patterned solid substrate is disposed on asurface of the solid elastomeric body opposite the surface of the solidelastomeric body on which the operative member is disposed. In someembodiments, the patterned solid substrate is disposed on a surface ofthe solid elastomeric body, and the operative member is disposed on thepatterned solid substrate such that the patterned solid substrate isintermediate the solid elastomeric body and the operative member. Whenthe patterned solid substrate is used in conjunction with the solidelastomeric body, the patterned solid substrate can generally have aperimeter shape similar or identical to the perimeter shape of the solidelastomeric body. For example, when the solid elastomeric body has apaddle shape, the patterned solid substrate can also have a paddleshape. The patterned solid substrate shaped like a paddle can havesimilar features as the paddle-shaped solid elastomeric body, such as arounded distal tip and a tapered proximal end. The perimeter of thepatterned solid substrate can be interior to the perimeter of the solidelastomeric body, coextensive with the perimeter of the solidelastomeric body, or portions or all of the patterned solid substratecan be exterior to the perimeter of the solid elastomeric body.

With reference to FIG. 11A, a patterned solid substrate 1605 havingportions of the patterned solid substrate 1605 removed to form splines1610 and voids 1615 is shown in accordance with various embodiments. Thepatterned solid substrate 1605 can include a distal end 1620, a proximalend 1625, and a central axis extending from the proximal end 1625 to thedistal end 1620 of the patterned solid substrate 1605.

The pattern of splines 1610 and voids 1615 can include any pattern thatprovides support to an operative member and promotes expansion betweenan expanded configuration and a collapsed configuration. In FIG. 11A,the patterned solid substrate 1605 is shown in an expanded configurationin accordance with various embodiments, which can generally includeproviding a substantially planar, curviplanar surface, or surface thatconforms to the target treatment area surface.

In various embodiments, including the embodiment shown in FIG. 11A, thepatterned solid substrate 1605 includes a central axis spline 1630 thatsubstantially overlaps the central axis of the patterned solid substrate1605. The central axis spline 1630 can be coupled with the guideassembly 110-e at the proximal end 1625 of the patterned solid substrate1605. In some embodiments, the guide assembly 110-e and the central axisspline 1630 are a unitary piece. The patterned solid substrate 1605 canalso be patterned so as to include an outer perimeter portion 1655 thatdefines and extends around the outer perimeter of the patterned solidsubstrate 1605.

In some embodiments, the patterned solid substrate 1605 is patternedsuch that a first subset of splines and a second subset of splines areformed. The first subset of splines can be arranged parallel with oneanother and can extend from the central axis spline towards a firstlateral peripheral edge of the patterned solid substrate 1605. Thesecond subset of splines can be arranged parallel to one another and canextend from the central axis spline 1630 towards a second lateralperipheral edge of the patterned solid substrate 1605, the secondlateral peripheral edge being opposite the first lateral peripheraledge. In some embodiments, the width and/or thickness of the firstsubset of splines and the second subset of splines is less than thewidth and/or thickness of the central axis spline 1630. In someembodiments, the first subset of splines and the second subset ofsplines extend away from the central axis spline 1630 until they eachconnect with the outer perimeter portion 1655 of the patterned solidsubstrate 1605.

In some embodiments, both the first subset of splines and the secondsubset of splines extend away from the central axis spline 1630 andtowards the distal end 1620 of the patterned solid substrate 1605. Inthis manner, the first subset of splines and the second subset ofsplines extend away from the central axis spline 1630 at an angle, whichcan range from greater than 0 degrees (which would be close to parallelwith the central axis spline 1630) to 90 degrees (which would beperpendicular to the central axis spline 1630). In some embodiments, theangle of the first subset of splines is the same as the angle of thesecond subset of splines, while in other embodiments, the angle of thefirst subset of splines is different from the angle of the second subsetof splines. In some embodiments, the angle of the first subset ofsplines and the second subset of splines is about 45 degrees. When thefirst subset of splines and the second subset of splines protrude awayfrom the central axis spline 1630 towards the distal end 1620, this canhelp promote the transition of the patterned solid substrate 1605between the expanded configuration and the collapsed configuration whenthe patterned solid substrate 1605 is being drawn back into a workingchannel. This spline pattern can behave similar to a feather being drawnback into a tube.

FIG. 11B illustrates a patterned solid substrate 1605-a in accordancewith various embodiments that may be an example of the patterned solidsubstrate 1605 shown in FIG. 11A. The patterned solid substrate 1605-amay include a central axis spline 1630-a, multiple splines 1610-a andmultiple voids 1615-a. The multiple splines 1610-a can be divided upinto a first subset of splines and a second subset of splines asdescribed above with reference to FIG. 11A. The patterned solidsubstrate 1605-a can also include a flexible support 155-j as describedin greater detail above with respect to FIGS. 6-8. The flexible support155-j, which can be made of nitinol, for example, can be located oneither surface of the patterned solid support 1605-a. In someembodiments where the patterned solid support 1605-a is used with asolid elastomeric body, the solid elastomeric body can be locatedbetween the patterned solid support 1605-a and the flexible support155-j.

The patterned solid support 1605-a can also include vias 1650. The vias1650 can be provided for coupling an operative member disposed on oneside of the patterned solid substrate 1605-a to buses located on theopposite side of the solid patterned substrate 1605-a. Any number ofvias 1650 can be provided, and the vias 1650 can be located anywherethroughout the patterned solid substrate 1605-a. As shown in FIG. 11B,the vias 1650 can interrupt the pattern of the patterned solid substrate1605-a.

Other patterns in the patterned solid substrate can also be used. Invarious embodiments, the pattern is a repeating pattern. The pattern maybe formed of a repeating shape or shapes. For example, the pattern maybe a repeating diamond, triangle, or square. The pattern may be arepeating polygonal shape of three, four, or more sides. In variousembodiments, the pattern is formed of two or more different patterns indifferent regions. For example, outer edges of the patterned solidsubstrate may have a different pattern than the inner, central region.The patterns may be similarly shaped but formed of splines withdifferent dimensions and spacing. As with the pattern shown in FIGS. 11Aand 11B, these other patterns can affect the properties of patternedsolid substrate, such as the expansion force of the patterned solidsubstrate.

With reference to FIG. 12A and/or FIG. 12B, an alternate pattern caninclude a criss-cross pattern with vertical splines 2005 and horizontalsplines 2010, where the vertical direction generally includes from theproximal end 1625-a to the distal end 1620-a and substantially parallelto the central axis in accordance with various embodiments. Thehorizontal splines 2010 can be orthogonal or perpendicular to thevertical splines 2005. The vertical splines 2005 and horizontal splines2010 can have substantially the same width. The vertical splines 2005can be elongated from the proximal end 1625-a to the distal end 1620-aof the patterned solid support 1605-b. The horizontal splines 2010 canextend a short distance, typically between adjacent vertical splines2005. The horizontal 2010 can be offset from each other with non-uniformspacing in an axial direction. Adjacent vertical splines 2005 can bespaced an equidistant amount. The patterned solid substrate 1605-b canalso include one or more vias 1650-a at various locations, which maydisrupt the pattern. Such a pattern of relatively long vertical splines2005 with regular spacing can promote the folding or rolling action ofthe patterned solid substrate 1605-b. In a transverse direction, bycontrast, the patterned solid substrate can be relatively rigid. Suchrigidity can improve maneuverability and improve apposition force.

FIGS. 13A to 13L illustrate various alternative patterns suitable foruse in the patterned solid substrate in accordance with variousembodiments. FIG. 13A illustrates a patterned solid substrate 1605-cwith a pattern of orthogonal splines that may be similar in variousrespects to the pattern shown in FIGS. 12A and 12B in accordance withvarious embodiments. The pattern may include vertically-extendingsplines 2005-a spaced from each other and horizontally-extending splines2010-a. The spacing between the splines may vary. In some embodiments,the spacing between adjacent vertical splines 2005-a along the outeredges is greater than the spacing between adjacent splines in theinterior of the pattern. This may be useful to increase the elasticityof the patterned solid substrate 1605-c along the outer edges. The widthof each of the splines may vary across the patterned solid substrate1605-c.

FIG. 13B illustrates a pattern of cross-hatched splines 1610-b inaccordance with various embodiments. The pattern depicted in FIG. 13Bmay be similar in various respects to the pattern shown in FIGS. 12A and12B, except that the pattern may be skewed in accordance with variousembodiments. The pattern need not repeat across the entire body of thepatterned solid substrate 1605-d. The pattern can repeat along distalend 1620-b of the patterned solid substrate 1605-d. Along anintermediate section, the pattern can be relatively random. One of theseries of splines can be incomplete. The pattern can begin to repeatagain along the proximal end 1625-b of the patterned solid substrate1605-d.

FIG. 13C illustrates a patterned solid substrate 1605-e wherein therecan be two different repeating patterns of shapes in accordance withvarious embodiments. The distal end 1620-c may include a repeatingpattern of squares and octagons. The proximal end 1625-c may have ahoneycomb-shaped pattern of hexagons.

FIG. 13D illustrates a patterned solid substrate 1605-f having acombination of various patterns in accordance with various embodiments.A distal end 1620-d can include multiple wavy splines 1610-c-1 generallypointed in a common direction, for example, a vertical direction. Anintermediate section can have a splines 1610-c-2 in a checkered pattern.A proximal section 1625-d can have a pattern of different splines1610-c-3. Some of the splines 1610-c-3 can be straight, some can bewavy, and some can have jagged shapes.

FIG. 13E and/or FIG. 13F illustrate a patterned solid support 1605-gwith a pattern of splines 1610-d in accordance with various embodiments,which may be similar to the pattern shown in FIGS. 12A and 12B. Thesplines 1610-d can be formed into vertical sections and horizontalsections. The horizontal sections can be staggered and have varyinglengths. The lengths can be defined by the spacing between verticalspline sections. A spacing between adjacent vertical spline sections canbe about 0.016 inch, for example. A width of each of the vertical andhorizontal spline sections can be about 0.016 inch. An exception can bethe spline sections defining a border of cut-outs. These splinessections can be about 0.008 inch.

The patterned solid substrate 1605-g can be integrally formed with acentral axis flexible support 155-k. The central axis flexible support155-k can be configured as a backbone that extends along and is alignedwith the central axis of the patterned solid substrate 1605-g. Thecentral axis flexible support 155-k can have a width and/or thicknesslarger than a width and/or thickness of the splines 1610-d. Thepatterned solid substrate 1605-g can overhang the central axis flexiblesupport 155-k at a distal end 1620-e.

FIG. 13G and/or FIG. 13H illustrate a patterned solid substrate 1605-h,which may be similar to the pattern shown in FIGS. 12A and 12B, inaccordance with various embodiments. The patterned solid substrate1605-h can have relatively narrower horizontal splines 2005-b, such as,for example, a width of about 0.008 inch. As described herein, thehorizontal splines 2010-b can play a role in the expanding andcollapsing of the patterned solid substrate 1605-h. In part, thevertical splines 2005-b may roll around each other like a flag whereasthe horizontal splines 2010-b generally bend. The narrower splinesections thus can result in a patterned solid substrate 1605-h with alower expansion/collapsing force. This can make the patterned solidsubstrate 1605-h easier to retract into the working channel while alsolowering the force for expansion.

FIG. 13I, FIG. 13J, and/or FIG. 13K illustrate patterns with variousspline spacings and alternative void dimensions in accordance withvarious embodiments. The patterns may be otherwise similar to thepattern shown in FIGS. 12A and 12B.

FIG. 13I illustrates a patterned solid substrate 1605-i having a patternwith multiple splines 1610-e arranged vertically and horizontally inaccordance with various embodiments. By contrast to some of the splinepatterns described above, the horizontal sections adjacent the centralaxis can be relatively longer thereby providing wider voids. Thisconfiguration can result in a lower bending force required adjacent thecentral axis than along the outer edges of the patterned solid support1605-i. In operation, the patterned solid substrate 1605-i tends to foldinto a U-shape.

FIG. 13J illustrates a patterned solid substrate 1605-j having a patternwith multiple splines 1610-f arranged vertically and horizontally inaccordance with various embodiments. By contrast to some of the splinepatterns described above, the pattern has can have relatively largevoids. The larger voids can result in a weaker patterned solid substrate1605-j, and by the same token, a lower expansion force. The relativelyuniform distribution and size of the voids can lead to relativelyuniform bending.

FIG. 13K and/or FIG. 13L illustrate a patterned solid substrate 1605-khaving a pattern, which may be similar to the pattern shown in FIGS. 12Aand 12B, in accordance with various embodiments. FIG. 13L may provide atop end view of the patterned solid substrate 1605-k illustrating acentral axis flexible support 155-1 positioning relative to thepatterned solid substrate 1605-k in the deployed configuration. Thepatterned solid substrate 1605-k may include multiple splines 1610-garranged vertically and horizontally. The pattern of splines 1610-g maydefine voids 1615-b with rectangular shapes. The voids 1615-b maygenerally have a shorter height than width. By the same token, a spacebetween adjacent horizontal spline sections may generally be smallerthan the length of the vertical spline sections. The patterned solidsubstrate 1605-k can also include a several horizontal spline sectionsthat extend across the entire width of the patterned solid substrate1605-k. The horizontal sections can be interrupted by a central axisflexible support 155-1.

The pattern shown can have a lower spline density than some of thepreviously described patterns. The spline density may refer to a ratioof the area of the splines to an area of the voids in a given section.Put another way, the spline density may refer to the material remainingrelative to the amount of material removed to form the voids.

In any of the patterns used, including those described above, thedimensions of the splines and voids can vary greatly to produce varyingeffects on the ability to transition the patterned solid substratebetween a collapsed configuration and an expanded configuration. Theoverall dimensions of the patterned solid substrate can also impact thecollapsing and expanding of the patterned solid substrate.

In various embodiments, the width of the patterned solid substrate isabout 7 mm. In various embodiments, the width of the patterned solidsubstrate is about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm,about 8 mm, about 9 mm, or more than 10 mm. In various embodiments, thepatterned solid substrate has a width of about 0.2 inch, 0.27 inch, or0.276 inch. Other embodiments may include other widths of the patternsolid substrate.

In various embodiments, the splines may be about 0.015 inch in width.The width of the splines may be based on the thickness of the patternedsolid substrate. For example, the width of the splines may beproportional to the thickness of the patterned solid substrate. Invarious embodiments, a width of the splines is between about 0.008 inchand about 0.02 inch, between about 0.008 inch and about 0.015 inch,between about 0.01 inch and about 0.02 inch, or between about 0.01 inchand about 0.015 inch. Other embodiments may include other widths of thesplines.

In various embodiments where the pattern includes vertical andhorizontal splines, the patterned solid substrate includes verticalsplines having a width of about 0.008 inch, about 0.01 inch, about 0.012inch, about 0.015 inch, about 0.016 inch, about 0.02 inch, or about 0.03inch, and horizontal splines having a width of about 0.008 inch, about0.01 inch, about 0.012 inch, about 0.015 inch, about 0.016 inch, about0.02 inch, or about 0.03 inch. In various embodiments, the patternedsolid substrate includes vertical splines having a width of about 0.03inch and horizontal splines having a width of about 0.01 inch, 0.02inch, or a combination thereof. In various embodiments, the patternedsolid substrate includes vertical splines having a width of about 0.016inch and horizontal splines having a width of about 0.01 inch, about0.016 inch, about 0.02 inch, or a combination thereof. In variousembodiments, the patterned solid substrate includes vertical splineshaving a width of about 0.016 inch and horizontal splines having a widthof about 0.012 inch. In various embodiments, the patterned solidsubstrate includes vertical splines and horizontal splines having widthsof about 0.016 inch. In various embodiments, the patterned solidsubstrate includes splines having widths ranging from about 0.01 inch toabout 0.03 inch. In various embodiments, the patterned solid substrateincludes vertical splines and horizontal splines having widths of about0.008 inch. Other embodiments may include other widths of the splines.

In various embodiments, a spacing (void width) between adjacent verticalsplines is about 0.016 inch, about 0.024 inch, greater than 0.03 inch,or greater than 0.04 inch. In various embodiments, a spacing betweenadjacent horizontal splines (void length) is about 0.016 inch, about0.024 inch, greater than 0.05 inch, greater than 0.1 inch, greater than0.2 inch, or greater than 0.3 inch. As explained herein, the pattern mayinclude splines in an angled orientation whereby the splines are nothorizontal or vertical. In various embodiments, a spacing betweenadjacent splines is about 0.016 inch, about 0.024 inch, greater than0.05 inch, greater than 0.1 inch, greater than 0.2 inch, or greater than0.3 inch. Other embodiments may include other widths of the voids.

The patterned solid substrate can be formed of a material having atleast highly elastic or superelastic properties, shape memoryproperties, or both. In various embodiments, the patterned solidsubstrate is formed of a superelastic material (SEM). In variousembodiments, the patterned solid substrate is formed of a shape memorymetal or shape memory alloy (SMA). Suitable materials for the patternedsolid substrate may include, but are not limited to, nickel-titanium,copper-aluminum-nickel, copper-zinc-aluminum, iron-manganese-silicon,and alloys of the same. The patterned solid substrate may also be formedof other materials. In some embodiments, the patterned solid substrateis formed of material having highly elastic material, including, but notlimited to, spring steel. In some embodiments, highly elastic materialincludes material having a yield strength in the range of from about 400MPa to about 1100 MPa.

In some cases the material of the patterned solid substrate is selectedbased on the application. For example, if the patterned solid substratemay need to collapse to a larger degree and thus may experience largestrains, nitinol may be more suitable than spring steel. One mayappreciate from the description herein, however, that a number offactors affect the amount of strain experienced by the component such asthe shape, the spline pattern, and the interaction with othercomponents.

Superelastic materials typically permit large elastic (recoverable)deformations. For example, SEMs may withstand 22.5% deformation withhigh damping under loads in the kN/mm range for solid wires and about 10to about 100 N/mm for tubes with an outer diameter of 0.4-2 mm.Recoverable deformations as great as 60% or more have been observed withthin-walled SEM tubes. This phenomenon is sometimes referred to as“giant superelasticity effect” (GSE). In various embodiments, thepatterned solid substrate 1605 is formed of a SEM. In variousembodiments, the patterned solid substrate 1605 is formed of a materialhaving GSE properties.

In some embodiments, the patterned solid substrate is formed ofnickel-titanium. Nickel-titanium is often referred to as nitinol (i.e.,Nickel-Titanium Naval Ordinance Laboratory). Nickel-titanium is known tohave both shape memory and superelastic properties. A nickel-titaniumalloy is sometimes made from a nearly equal composition of nickel andtitanium. The performance of nitinol alloys are generally based on thephase transformation in the crystalline structure, which transitionsbetween an austenitic phase and a martensitic phase. The austeniticphase is generally called the high temperature phase, and themartensitic phase is called the low temperature phase. In themartensitic phase the material has a relatively low tensile strength andis stable at relatively low temperatures. In the austenitic phase, thematerial generally has a relatively high tensile strength and is stableat temperatures higher than the martensitic phase. The phasetransformation is the general mechanism by which superelasticity and theshape memory effect are achieved.

Shape memory generally implies that the alloy can be inelasticallydeformed into a particular shape in the martensitic phase, and whenheated to the austenitic phase, the alloy transforms back to theparticular shape. Thus, at elevated temperatures the material canexperience recoverable strains. For typical nitinol, the transformationtemperature (Af) may be about 50° Celsius. The Af temperature may varydepending on the application. In various embodiments, the Af temperatureof the support member is selected to be about 15° C. In variousembodiments, the Af temperature of the support member is selected tobelow 20° C. Methods for adjusting the transformation temperature ofnitinol are generally known as exemplified by U.S. Pat. No. 4,283,233 toGoldstein et al, incorporated by reference for all purposes.

Superelasticity or pseudoelasticity generally refers to the relativelyhigh elasticity of the alloy when placed under stress and without theinvolvement of heat. For example, it is possible to see reversiblestrains of 8 percent or more elongation in a superelastic nitinol wireas compared to 0.5 percent reversible strain in a comparable steel wire,for example. The superelastic property may appear in the austeniticphase when stress is applied to the alloy and the alloy changes from theaustenitic phase to the martensitic phase. This particular martensiticphase may more precisely be known as stress-induced martensite (SIM).The phase is generally unstable at temperatures above the phasetransformation temperature and below the temperature known as Md. Attemperatures above Md, stress-induced martensite cannot be achieved andthe superelastic properties are lost. Within this temperature range,however, the stress-induced martensite may revert back to the austeniticphase after the force is removed. This phase change may enable therecoverable strains characteristic of nitinol.

When stress is applied to a specimen of a metal having superelasticcharacteristics (at or above the transformation temperature), thespecimen generally deforms elastically until it reaches a particularstress level where the alloy then undergoes SIM. As the phasetransformation progresses, the alloy may undergo significant increasesin strain with little or no corresponding increases in stress until thetransformation of the austenitic phase to the martensitic phase iscomplete. Thus, the metal generally first deforms elastically and thenplastically deforms.

In various embodiments, the patterned solid substrate is formed of ashape memory material. In various embodiments, the patterned solidsubstrate is entirely formed of a shape memory material. In variousembodiments, the patterned solid substrate is formed of a materialhaving superelastic properties. In various embodiments, the patternedsolid substrate is entirely formed of a material having superelasticproperties. In various embodiments, the patterned solid substrate isformed of nitinol. One may appreciate that other superelastic and/orshape memory materials may be used in accordance with variousembodiments of the inventions. The patterned solid substrate may makeuse of the superelastic properties, shape memory properties, or bothproperties of the shape memory material.

In various embodiments, the patterned solid substrate is formed of ashape memory alloy and makes use of the material's unique properties.The shape memory effect may allow the patterned solid substrate to bedeformed into the collapsed configuration to facilitate its insertioninto a working channel. Thereafter, the patterned solid substrate may beheated within the working channel so that the patterned solid substrateis biased towards a predetermined collapsed shape. The predeterminedshape may be a specific shape as described above.

In various embodiments, the patterned solid substrate is designed tomake use of the superelastic properties of the shape memory alloy so itis disposed to expand and collapse within the working channel. Thesuperelastic property may allow the patterned solid substrate to expandagainst a tissue surface.

In some embodiments, patterned solid substrate is formed from a nitinolplate having a thickness of 0.003 inch. When the support member iscollapsed into a working channel, for example a 2.8 mm working channel,the patterned solid substrate may undergo about 3% to about 4% strain,for example. With conventional materials the patterned solid substratemay plastically deform under these conditions. With nitinol, however, ithas been found that the material can undergo about 6% to about 8%strain, for example, without plastic deformation. Thus, the patternedsolid substrate can easily fit within the working channel withoutplastic deformation.

In various embodiments, patterned solid substrate is formed of a shapememory alloy and configured to maintain the operative member in at leastone of the expanded configuration and the collapsed configuration.

Patterned solid substrate may make use of shape memory properties inother ways. In various embodiments, the patterned solid substrate isformed of a shape memory material with an initial transition temperature(Af) selected to permit the patterned solid substrate to easily rollinto the working channel during preparation and expand to a preset shapeonce exposed to the internal body temperature. For example, the Aftemperature may be between room temperature and normal body temperature.In other words, the material may be designed to be in the austeniticphase between room temperature and body temperature. In variousembodiments, the Af temperature is between about 23° C. and about 37°C., between about 25° C. and about 37° C., between about 25° C. andabout 40° C., between about 25° C. and about 45° C., between about 15°C. and about 45° C., between about 20° C. and about 35° C., betweenabout 15° C. and about 20° C., or between about 20° C. and about 30° C.Thus, the patterned solid substrate Af temperature may be selected sothe patterned solid substrate temperature rises in the body at whichpoint it wants to unroll into an expanded configuration. This processcould also be aided by the user flushing the patterned solid substratewith cold water to maintain the temperature below 25° C. and flushingthe patterned solid substrate with hot water when it is desired toactivate expansion.

An expandable support device, such as any of the expandable supportdevices described above, can be configured to support an operativemember. The operative member can be disposed on an outward facingsurface of the expandable support device. The operative member caninclude any operative member configured for providing therapy to atarget treatment area. In some embodiments, the operative member isconfigured for delivering energy including, but not limited to,radiofrequency (RF) energy, thermal energy, and electromagnetic energy.In various embodiments, the operative member is configured fordelivering a heated or cooled fluid or cryogenic fluid. In variousembodiments, the operative member is configured for laser treatment,microwave treatment, radio frequency ablation, ultrasonic ablation,photodynamic therapy using photo sensitizing drugs, argon plasmacoagulation, cryotherapy, and/or x-ray treatment.

In some embodiments, the operative member is also configured fortransitioning between a collapsed and expanded configuration such thatthe operative member can collapse and expand with the expandable supportdevice on which it is disposed. In some embodiments, the operativemember is flexible in order to accommodate this transition. In someembodiments, flexible operative member provides negligible resistance tomovement of the expandable support device on which it is disposed.

Other features of the operative member can also be designed to assistthe operative member in transitioning between a collapsed and expandedconfiguration, such as the design of electrodes which can be part of anoperative member. In some embodiments, electrodes included as part ofthe operative member are made from a malleable metal that resistschanges to shape but which is capable of bending to a certain extentwithout plastic deformation. If the malleable metal of the electrodes istoo rigid, it will affect, and in some cases prevent, the collapsing andexpanding movement. Another approach for making the operative memberflexible and conducive to transitioning between a collapsed and expandedconfiguration can be to design the operative member to decrease theresistance to bending in the desired direction. For example, anoperative member including multiple electrodes can include electrodesoriented in a direction parallel to the axis along which the bending ofthe operative member occurs during transition between collapsing andexpanding configurations so that the electrodes generally do not bend asthe operative member furls into the collapsed configuration.

In the case of therapy using radiofrequency energy, for example, theoperative member may include an electrode or electrode array connectedto an energy source configured as a radiofrequency generator. The RFgenerator can be connected using a coupling and connection line suitedto the transmission of electrical energy to the electrode array. Theelectrode array may be configured as at least a monopolar or bipolararray of electrodes. In the case of therapy using microwave energy, forexample, the operative member can include an appropriate antenna orarray connected to an energy source configured as a source of microwaveenergy. The microwave source can be connected using a coupling andconnection line suited to the transmission of microwave energy to theantenna or array. In the case of cryogenic therapy, for example, theoperative member can be an appropriate applicator for the cryogenic gasor liquid such as a nozzle, array of nozzles in the case of a spraydelivery, or a receptacle for a cryogenic fluid in the case where thetherapy is applied via contact with a low temperature receptacle. Thecryogenic applicator can be connected to the cryogenic source using acoupling and connection line suited to the controlled delivery of thecryogenic gas or liquid. In the case of photo-therapy, for example, theoperative member can provide the appropriate fixed or moving lens orlens array suited as appropriate for the light source being used. Thephotonic delivery element can be connected to the light source using acoupling and connection line suited to the controlled delivery of thelight or phototherapy energy generated by the phototherapy source.

With reference to FIG. 14A, an operative member 160-b in accordance withvarious embodiments is shown. The operative member 160-b can be disposedon a surface of an expandable support device 120-p, such as a solidelastomeric support. A flexible support 155-m can be provided on thesame surface or on an opposing surface of the expandable support device120-p. The flexible support 155-m can be aligned with the central axisof the expandable support device 120-p. The expandable support device120-p can be coupled with a guide assembly 110-f, which can be used tomove the expandable support device 120-p and the operative member 160-bthrough a working channel 115-f and around a target treatment area. Boththe operative member 160-b and the expandable support device 120-p canbe configured to transition between a collapsed and expandedconfiguration.

In some embodiments, the operative member 160-b includes a flexiblecircuit. The flexible circuit can include multiple electrodes 2205. Insome embodiments, the flexible circuit further includes a backing layeron which the electrodes are disposed. The backing layer, which caninclude an insulator, can then be disposed on the expandable supportdevice 120-p. In some embodiments, the electrodes 2205 are disposeddirectly on the expandable support device 120-p. Various aspects of theflexible circuit are similar to typical integrated circuits andmicroelectronic devices. The operative member 160-b may include variousoperative and adjunctive medical devices other than electrodes.

In some embodiments, the multiple electrodes 2205 are aligned inparallel to one another and can form a row of electrodes 2205 spanningat least a portion of the width of the expandable support device 120-p.The electrodes 2205 can be spaced evenly apart from one another and/orat varying distances. The multiple electrodes 2205 can generally bealigned in parallel with an axis that extends from a distal end 1105-dto a proximal end 1110-d of the expandable support device 120-p on whichthe operative member 160-b is disposed. In some embodiments, this axiswill be a central axis and will generally be located half way betweenopposing sides of the expandable support device 120-p. In someembodiments, the expandable support device 120-p is configured tocollapse around this central axis when transitioning to a collapsedconfiguration. By aligning the multiple electrodes 2205 to be parallelwith the central axis, the flexible circuit and the electrodes 2205 canalso be configured to collapse around the central axis, as theelectrodes 2205 will generally not resist the collapsing movement due totheir parallel orientation. In such embodiments, the individualelectrodes 2205 are not bent or deformed to a significant degree.Rather, the folding or collapsing may occur in the spaces between theelectrodes 2205, and more specifically, in the flexible expandablesupport device 120-p. Consequently the expansion force utilized forexpansion can be decreased.

In some embodiments, the flexible circuit extends to the perimeter ofthe expandable support device 120-p. Each electrode 2205 can extend froma proximal end 1110-d of the expandable support device 120-p to a distalend 1105-d of the expandable support device 120-p. In some embodiments,such as that shown in FIG. 14A, the multiple electrodes 2205 do notextend into the tapered portion of the proximal end 1110-d of expandablesupport device 120-p. The row of electrodes 2205 can extend to thelateral peripheral edges of the expandable support device 120-p. In someembodiments, the flexible circuit is generally coextensive with theshape of the expandable support device 120-p. In some embodiments, theflexible circuit is larger than the expandable support device 120-p suchthat a portion of the flexible circuit extends over a portion of theexpandable support device 120-p. In some embodiments, the flexiblecircuit is smaller than the expandable support device 120-p such that aportion of the expandable support device 120-p extends beyond theperimeter of the flexible circuit. One may appreciate from thedescription herein that the shapes and positional relationship of theexpandable support device 120-p and the operative member 160-b may bevaried in other ways.

In some embodiments, the multiple electrode 2205 provide a bipolarelectrode array. In such embodiments, the operative member 160-b caninclude a first bus 2215 and a second bus 2220. The first bus 2215 canbe either a source line or a drain line. When the first bus 2215 is asource line, the second bus 2220 can be a drain line, and when the firstbus 2215 is a drain line, the second bus 2220 can be a source line.Depending on whether the first bus 2215 is a source line or a drainline, the first bus 2215 can be coupled with a positive terminal or anegative or ground terminal. Similarly, depending on whether the secondbus 2220 is a source line or a drain line, the second bus 2220 can becoupled with a positive terminal or a negative or ground terminal.

In some embodiments, the first bus 2215 is coupled with a first subsetof the multiple electrodes 2205 and the second bus 2220 is coupled witha second subset of the multiple electrodes 2205. The first bus 2215 andthe second bus 2220 can couple to alternating electrodes 2205 in the rowof electrodes 2205 to thereby define the first subset of electrodes 2205and the second subset of electrodes 2205.

In some embodiments, the first bus 2215 is located at a first end of themultiple electrodes 2205 and the second bus 2220 is located at theopposite end of the multiple electrodes 2205. The first bus 2215 and thesecond bus 2220 can be arched. In some embodiments, the first bus 2215and the second bus 2220 are each a single arch extending the width ofthe expandable support device 120-p. The arched first bus 2215 locatedat the distal end 1105-d of the expandable support device 120-p can beparallel to the curvature of the distal end 1105-d, such as when theexpandable support device 120-p has a paddle shape. The arched first bus2215 at the distal end 1105-d of the expandable support device 120-p canbe coupled with the first subset of electrodes 2205, which may extendaway from the arched first bus 2215 towards the proximal end 1110-d. Insome embodiments, the first subset of electrodes 2205 do not connectwith the second bus 2220 at the proximal end 1110-d of the expandablesupport device 120-p. The arched second bus 2220 located near theproximal end 1110-d of the expandable support device 120-p can have anarch shape in the opposite direction of the first bus 2215 located atthe distal end 1105-d. In other words, the arch shape of the second bus2220 near the proximal end 1110-d of the expandable support device 120-pcan curve away from the distal end 1105-d of the expandable supportdevice 120-p. The second subset of electrodes 2205 can be coupled withthe arched second bus 2220 at the proximal end 1110-d of the expandablesupport device 120-p and extend away from the arched second bus 2220towards the distal end 1105-d of the expandable support device 120-p. Insome embodiments, the second subset of electrodes 2205 do not connectwith the first bus 2215 at the distal end 1105-d of the expandablesupport device 120-p.

With reference to FIG. 14B, the first bus 2215 and the second bus 2220can be at least partially covered with a material 2225 that may preventor impedes the transmission of energy to the target treatment area inaccordance with various embodiments. In some embodiments, the first bus2215 and the second bus 2220 are covered with an insulation material2225. Any suitable insulation material 2225 can be used, including, forexample, polyimide. Covering the first bus 2215 and the second bus 2220with insulation material 2225 can be useful to provide an operativemember 160-b that delivers a more square treatment pattern, which canprovide for more accurate and precise delivery of treatment to a targettreatment area. For example, when the operative member 160-b isconfigured to provide ablative energy, the operative member 160-b havinga covered first bus 2215 and second bus 2220 can deliver a squareablative pattern rather than one with rounded and less defined edges soas to provide for more accurate and precise ablation of the targettreatment area.

FIG. 15A and FIG. 15B illustrate a flexible circuit, which may besimilar to the flexible circuit shown in FIGS. 14A and 14B, inaccordance with various embodiments. The first bus 2215-a and the secondbus 2220-a provided can include multiple arches rather than a singlearch as shown in FIGS. 15A and 15B. In some embodiments, the end of eacharch is coupled with single electrode 2205-a. Thus, the end of each archincluded in the first bus 2215-a may be coupled with a single electrode2205-a in the first subset of electrodes, while the end of each archincluded in the second bus 2220-a may be coupled a single electrode2205-a in the second subset of electrodes. With reference to FIG. 15B,at least a portion of the first bus 2215-a including multiple arches andthe second bus 2220-a including multiple arches can be covered with aninsulation material 2225-a, such as polyimide.

While not shown in the FIGS. 14A, 14B, 15A, or 15B, in some embodiments,the first bus and second bus are located on a surface of the expandablesupport device opposite the surface on which the flexible circuit(including the multiple electrodes) is disposed. FIGS. 17A and/or 17Bmay show such configurations. In such embodiments, the expandablesupport device can include one or more vias. The first and second buscan be connected to the first subset of electrodes and the second subsetof electrodes, respectively, through the vias that provide a passage waybetween the front and back surface of the expandable support device. Thefirst bus and the second bus disposed on the second surface of theexpandable support device can be aligned substantially perpendicular tothe electrodes disposed on the first surface of the expandable supportdevice. The first bus and the second bus can be positioned at oppositeends of the electrodes as shown in FIGS. 14A, 14B, 15A, and 15B, at alocation between the first end and second ends of the electrodes, or acombination of the two.

Any suitable material can be used for the electrodes, first bus, and/orsecond bus described above. In some embodiments, at least one of theelectrodes, first bus, or second bus are made from copper. In someembodiments, the first bus and the second bus are made from copper. Insome embodiments, the first bus and the second bus can include a hashpattern that includes multiple voids within the first bus and the secondbus. This hash pattern, and specifically, the multiple voids, canimprove the ease with which the first bus and second bus are capable ofcollapsing when the expandable support device transitions to a collapsedconfiguration. In embodiments where the first bus and the second bus arealigned perpendicular to the electrodes (and therefore perpendicular tothe axis along which the expandable support device will collapse whentransitioning to a collapsed configuration), the hash pattern can resultin the first bus and the second bus providing less resistance to thecollapsing of the expandable support device.

In some embodiments, the electrodes described above are formed from apatterned layer of electrode material disposed on a backing layer or theexpandable support layer. After the layer of electrode material, whichcan include metal, for example, is disposed on an underlying support,traditional etching techniques can be used to remove portion so theelectrode material and provide electrodes in desired pattern, includingthe patterns described above. In some embodiments, a 1 ounce copper canbe used as the electrode material layer, and the electrode materiallayer can have a thickness of less than 0.01 inch thick. Other amountsof copper and/or thicknesses may be utilized in some embodiments.

The operative member can be attached to expandable support device withconventional fastening techniques, such as adhesives. In variousembodiments, the operative member is attached to the expandable supportdevice along an entire bottom surface. In various embodiments, only aportion of the operative member is attached to the expandable supportdevice. In various embodiments, all or a portion of the periphery of theoperative member is attached to the expandable support device. Theoperative member may be attached to the expandable support device onlyin selected regions, such as the center of the operative member. Invarious embodiments, the operative member is attached to the expandablesupport device in only selected locations to accommodate slippage orshearing between the structures. The operative member and its attachmentto the support member can influence movement of the expandable supportdevice between the collapsed to the expanded configurations.

With reference to FIG. 16A and/or FIG. 16B, an operative member 160-c inaccordance with various embodiments is shown. The operative member 160-ccan be an RF ablation circuit for delivering RF ablation to a tissuesurface. The operative member 160-c can include multiple electrodes2205-b on an insulator material 2405. The electrodes 2205-b can beconnected to a power source 105-b. The multiple electrodes 2205-b can beformed in a bipolar array. The electrodes 2205-b can be positioned overa source line first bus 2215-b and a drain line second bus 2220-b. Thesource line first bus 2215-b can be connected to a positive terminal ofpower source 105-b by an “in” line 2415, and the drain line second bus2220-b can be connected to the negative terminal or ground by an “out”line 2420. The source line first bus 2215-b and drain line 2220-b canextend below the electrodes 2205-b. The source line first bus 2215-b anddrain line second bus 2220-b may be configured as electrical bus lines.A portion of the multiple electrodes 2205-b can be connected to thesource line first bus 2215-b, and the remainder of the electrodes 2205-bconnected to the drain line second bus 2220-b. In some embodiments, theelectrodes 2205 are alternately connected to the source line first bus2215-b and drain line second bus 2220-b. When the power source 105-bactivates the electrodes 2205-b, energy can travel from the positiveelectrodes to the ground or negative electrodes.

Source line first bus 2215-b may be connected to “in” line 2415 througha via 1650-b. Likewise, drain line second bus 2220-b may be connected to“out” line 2420 by a via 1650-b. The vias 1650-b can extend through theexpandable support device 120-r. In various embodiments, the electrodes2205-b include wires that are inserted through the vias 1650-b andconnected to an electrical component or circuit below the expandablesupport device 120-r. In some embodiments, the “in” line 2415 and “out”line 2420 include a bundle of wires (e.g., Litz wires). The wires canextend through the guide shaft 110-g and connect to the power source105-b at an opposite end. In various embodiments, the vias 1650-b areoversized relative to the electrical connections to accommodate lateralmovement or shearing of the connections relative to the expandablesupport device 120-r during expansion and collapsing.

The electrodes 2205-b can be elongated and generally face in a commondirection. In various embodiments, the electrodes 2205-b are alignedwith a central axis of the expandable support device 120-r and/or theguide shaft 110-g. The operative member 160-c may include otherconfigurations such as one or more monopolar electrodes.

The electrodes may have a length of between about 1 mm and about 10 mm,between about 1 mm and about 7 mm, between about 1 mm and about 6 mm,between about 1 mm and about 5 mm, between about 1 mm and about 3 mm, orbetween about 1 mm and about 4 mm. In various embodiments, the electrodelength is between about 5 mm and about 50 mm, and in various embodimentsabout 15 mm. One may appreciate from the description herein that thelength of the electrodes may vary depending on the application andexpandable support device.

Each of the electrodes may have a width of about 4 mm, about 3 mm, about2 mm, about 1 mm, about 0.9 mm, about 0.8 mm, about 0.7 mm, about 0.6mm, about 0.5 mm, about 0.4 mm, about 0.3 mm, about 0.2 mm, or about 0.1mm. In various embodiments, each electrode has a width of less than 1mm. In various embodiments, each electrode has a width of about 0.25inch. In various embodiments, an average width of the electrodes isabout 4 mm, about 3 mm, about 2 mm, about 1 mm, about 0.9 mm, about 0.8mm, about 0.7 mm, about 0.6 mm, about 0.5 mm, about 0.4 mm, about 0.3mm, about 0.2 mm, or about 0.1 mm. In various embodiments, an averagewidth of the electrodes is less than 1 mm. One may appreciate from thedescription herein that the electrodes may have different widths and/orlengths.

In various embodiments, a spacing between adjacent electrodes is basedon the electrode length, width, shape, or a combination of the same. Insome embodiments, the spacing between the electrodes is fixed byfastening the electrodes to a backing layer or the expandable supportdevice. The spacing between adjacent electrodes may be between 0 mm andabout 1 mm, between about 0 mm and about 0.5 mm, between about 0 mm andabout 0.4 mm, between about 0 mm and about 0.3 mm, or between about 0 mmand about 0.2 mm. The spacing between adjacent electrodes may be lessthan 0.3 mm, less than 0.2 mm, less than 0.1 mm, or less than 0.05 mm.In various embodiments, the spacing between adjacent electrodes is about0.3 mm. One may appreciate from the description herein that theelectrodes may have different spacing.

One may appreciate that the dimensions and lay out of the electrode mayvary depending on the application. For example, if the working channelis larger, it may be desirable to use an expandable support device witha larger treatment surface and/or larger electrodes. A larger targettreatment surface can typically require scaling up the constituentelements including the operative members.

One may appreciate from the description herein that the operative membermay be configured differently depending on the application requirements.In various embodiments, the operative member includes multiple electrodearrays. The arrays can be individually powered. The number and type ofelectrodes may also vary.

In various embodiments, the dimensions of the electrodes and spacingbetween the electrodes are selected to enable controlled depth ablation.Examples of electrode configurations for controlled depth ablation aredescribed in U.S. Pat. No. 6,551,310 (Ganz et al.), U.S. Pat. No.7,150,745 (Stern et al.); U.S. Pat. No. 7,344,535 (Stern et al.); U.S.Pat. No. 7,530,979 (Ganz et al.); U.S. Pat. No. 7,993,336 (Jackson etal.); U.S. Pat. No. 8,012,149 (Jackson et al.); and U.S. Patent Pub.Nos. 2008/0097427 (Stern et al.); 2009/0012513 (Utley et al.), and2009/0048593 (Ganz et al.); the entire contents of which patents andpatent publications are hereby incorporated herein for all purposes. Invarious embodiments, the power generator and/or a controller areconfigured to control the application of energy using the operativemember to effect ablation of tissue to a controlled depth.

In some embodiments, the electrodes 2205-b shown in FIGS. 16A and 16Bare oriented parallel to an axis about which the collapsing andexpanding of the expandable support member 120-r occurs in order topromote the collapsing and expansion functions.

Although the electrodes 2205-b can be separated from the expandablesupport device 120-y by an insulator layer 2405, the electrodes 2205-bmay influence each other during bending. For example, if the electrodes2205-b are fastened to a insulator layer 2405 in a way that makes theresulting circuit more rigid, this may resist bending of the expandablesupport device 120-r. In various embodiments, the electrodes 2205-b arepositioned on the expandable support device 120-r to minimizeoverlapping with other support structures, such as the support splines.In various embodiments, the electrodes and splines are positioned andconfigured in an intersecting relationship.

FIGS. 17A-17D illustrate an operative member 160-d in the form of aflexible circuit in accordance with various embodiments. The operativemember 160-d can be attached to a top surface of the expandable supportdevice. FIG. 17A shows a top side of operative member 160-d. FIG. 17Bshows a back side of the operative member 160-d. FIG. 17C is an enlargedview of a portion of the operative member 160-d as seen from the topside. The operative member 160-d can be configured as an adhesive stripfor applying to the expandable support device.

In some embodiments, the expandable support device on which theoperative member 160-d is disposed is about 7 mm to about 8 mm in width.The operative member 160-d can include an electrode array 2505 thatextends across all or substantially all of the expandable support devicewidth. In some embodiments, the electrode array 2505 can have a widthbetween about 7 mm and about 8 mm. The width of the expandable supportdevice and/or the electrode array 2505 may depend on the size of theworking channel through which they are intended to be deployed.

In some embodiments, the electrode array 2505 includes twelve electrodes2205-z in the shape of bars. In some embodiments, the electrodes 2205-ccan be formed of 1 ounce copper on each side of an insulator sheet orbacking. In some embodiments, each electrode 2205-c can have a widthbetween about 0.2 inch and about 0.3 inch, and preferably 0.25 inch. Insome embodiments, the spacing between adjacent electrodes 2205-c can bebetween about 0.25 inch and about 0.4 inch, and preferably 0.3 inch. Thelength of the electrodes 2205-c can vary. In some embodiments, theelectrodes 2205-c positioned interiorly are longer than the electrodes2205-c along the sides of the operative member 160-d. In variousembodiments, the electrodes 2205-c along the central axis have thegreatest length, and the length decreases moving towards the sides ofthe electrode array 2505. In some embodiments, electrode array 2505defines a rounded treatment surface. The distal edge 2510 and proximaledge 2515 of the electrode array 2505 can be curved.

The operative member 160-d can include an array of electrodes 2505 on aninsulator material 2405-a with an adhesive backing. The electrodes2205-c can extend in a longitudinal direction on a top surface of theinsulator material 2405-a. As shown in FIG. 17B, the back side of theinsulator material 2405-a may include a first bus 2215-c and a secondbus 2220-c in accordance with various embodiments. As shown in FIG. 17C,each of the electrodes 2205-z on the top surface can be connected to oneof the first bus 2215-c or the second bus 2220-c by vias 1650-c inaccordance with various embodiments. The first bus 2215-c and the secondbus 2220-c can be formed of copper over the insulator material 2405-a.The first bus 2215-c and second bus 2220-c can have a hatched pattern.

The operative member can include solder pads 2520. In some embodiments,the operative member 160-d includes two pads 2520 for the positive andnegative terminals. One may appreciate that the operative member 160-dmay include one, two, or more pads and buses depending on theconfiguration. For example, the operative member 160-d may be configuredas a monopolar electrode array with a single bus line.

With reference to FIG. 17D, the operative member 160-d can includes line2415-a for connecting the first bus 2215-c to a positive terminal and aline 2420-a for connecting the second bus 2220-c to ground in accordancewith various embodiments. The lines 2415-a and 2420-a can be connectedto the first bus 2215-c and the second bus 2220-c, respectively, by thepads 2520. Pads 2520 can be shaped and positioned for inserting intocut-outs in an expandable support device.

Although described in terms of an electrode array for RF ablation, onemay appreciate that the operative members suitable for use embodimentsdescribed herein may be configured for administering other forms oftherapy or diagnosis. For example, the techniques described above may beapplied to form an antenna for microwave ablation. In another example,the operative member may include sensor elements overlaying theexpandable support device. Monopolar RF configurations can also be usedin some embodiments. Some embodiments may utilize bipolar RFconfigurations.

In various embodiments, the operative members described herein areablation devices, and in some embodiments, RF ablation devices. Invarious embodiments, the operative members described herein areconfigured for thermal ablation. In some embodiments, the operativemembers described herein are configured to heat surrounding tissue byresistive heating or conduction. Embodiments of operative membersdescribed herein can be configured to treat or diagnose the surroundingtissue by other modalities.

In various embodiments, the operative members described herein areconfigured for ablation of abnormal tissue in the esophagus. In variousembodiments, the operative members described herein are configured forablation of abnormal tissue in the lower esophageal sphincter. Invarious embodiments, the operative members described herein areconfigured for ablation of Barrett's esophagus and/or pre-canceroustissue in the epithelium without injuring the underlying muscalaris. Invarious embodiments, the operative members described herein areconfigured for use in a variety of body lumens and organs including, butnot limited to, the gastrointestinal (GI) tract (e.g. the esophagus orduodenum), the alimentary tract, the digestive system (e.g. the bileduct), the cardiovascular system, the endocrine system (e.g. thepancreas), and the respiratory system.

In various embodiments, the operative members described herein areconfigured to ablate tissue to a predetermined depth. In variousembodiments, the operative members described herein are configured toablate mucosal tissue without injuring the underlying submucosal tissue.In various embodiments, the operative members described herein areconfigured to ablate mucosal tissue without injuring the underlyingmuscalaris. In various embodiments, the operative members describedherein are configured to apply the appropriate level of energy to thetissue to achieve an ablation depth that does not extend beyond thesubmucosa layer of the esophagus. In various embodiments, the operativemembers described herein are configured to control the depth of ablationto the epithelium. In various embodiments, the operative membersdescribed herein are configured for superficial ablation. For example,various embodiments of an operative member may be configured to sear thetissue surface. In various embodiments, the operative members describedherein are configured to deliver sufficient energy to initiate regrowthof tissue, for example, in a mucosal layer.

Controlling the depth of ablation is based on several factors such aspower and treatment time. In various embodiments, the power sourceactivates the electrode array with sufficient power and for a sufficientamount of time to ablate tissue to a predetermined depth. In anexemplary embodiment, the power source activates the electrode arraywith sufficient power and for a length of time necessary to deliverbetween about 1 J/sq.-cm and about 50 J/sq.-cm, between about 10J/sq.-cm and about 40 J/sq.-cm, between about 15 J/sq.-cm and about 105J/sq.-cm, between about 25 J/sq.-cm and about 105 J/sq.-cm, betweenabout 30 J/sq.-cm and about 105 J/sq.-cm, between about 35 J/sq.-cm andabout 105 J/sq.-cm, or between about 40 J/sq.-cm and about 105 J/sq.-cm.Other energy per unit area amounts may be utilized in some embodiments.

In various embodiments, the operative member is configured to deliverbetween about 10 Watts/sq.-cm and about 50 Watts/sq.-cm, between about10 Watts/sq.-cm and about 40 Watts/sq.-cm, between about 10 Watts/sq.-cmand about 30 Watts/sq.-cm, between about 15 Watts/sq.-cm and about 30Watts/sq.-cm, or between about 15 Watts/sq.-cm and about 40Watts/sq.-cm. Other energy per unit area amounts may be utilized in someembodiments.

In various embodiments, the power generator is configured to activatethe electrodes for between about 10 ms and about 5 minutes, betweenabout 100 ms and about 1 minute, between about 100 ms and about 30seconds, between about 10 ms and about 1 second, between about 100 msand about 1 second, or between about 300 ms and about 800 ms. In variousembodiments, the power generator is configured to activate theelectrodes for less than 1 second, less than 500 ms, or less than 300ms. In some embodiments, the operative member is configured to deliverabout 40 W/sq.-cm for a duration of about 300 ms to about 800 ms. Insome embodiments, the operative member is configured to deliver betweenabout 12 J/sq.-cm to about 15 J/sq.-cm for a duration of about 300 ms toabout 800 ms. Other energy per unit area amounts and time amounts may beutilized in some embodiments.

In some embodiments, a guide assembly is provided for delivering andpositioning an expandable support device and an operative memberdisposed thereon through a working channel and to a target treatmentarea. The guide assembly can include one or more guide shafts. Eachguide shaft can generally include a relatively long and thin cylindricalbody. Each guide shaft can include a proximal end and a distal end. Insome embodiments, the distal end of one guide shaft is coupled with theexpandable support device and the proximal end of one guide shaft iscoupled with a power source.

The material of each guide shaft is generally not limited. Suitablematerials for the guide shafts include, but are not limited to, metalsand thermoplastics. The material of the guide shafts can be rigid,flexible, or include sections of both rigid and flexible material. Invarious embodiments, the guide shafts are formed of the same material asthe expandable support device. One of the guide shafts may be integrallyformed with the expandable support member or formed as a separate piece.When the guide shaft is a separate piece from the expandable supportmember, the guide shaft can be coupled with the expandable supportdevice using any suitable material or technique, such as, for example,by welding or adhesives.

In various embodiments, the guide shafts have a uniform thickness. Invarious embodiments, the guide shafts have a thickness of about 0.01inch, about 0.012 inch, or about 0.002 inch. In various embodiments, theguide shafts have a thickness of 0.012 inch+/−0.0005 inch.

With reference to FIG. 18A, a guide assembly 110-h is shown inaccordance with various embodiments. The guide assembly 110-h caninclude two separate shaft sections through which one or moretransmission wires 3105 can pass. The first shaft 112-a (which can alsobe referred to as a distal shaft) and the second shaft 114-a (which canalso be referred to as a proximal shaft or the power source side shaft)are separated by a break 140-a. The first shaft 112-a can extend fromthe break 140-a up towards the expandable support device coupled withthe distal end of the guide assembly 110-h. The second shaft 114-aextends back from the break towards the power source used to supplypower to the expandable support device. The first shaft 112-a and thesecond shaft 114-a can be configured to axially move an expandablesupport device and an operative member disposed thereon, such as axiallythrough a working channel.

The one or more transmission lines 3105 can be configured foroperatively connecting an operative member to a power source.Accordingly, in some embodiments, the transmission lines 3105 have aproximal end coupled with a power source and a distal end coupled withan operative member on an expandable support device while extendingthrough both the second shaft 114-a and the first shaft 112-a of theguide assembly 110-h. In this manner, the first shaft 112-a and thesecond shaft 114-a enclose at least a portion of the one or moretransmission lines 3105. In some embodiments, the one or moretransmission lines 3105 are exposed at the break 140-a due the firstshaft 112-a being separated from the second shaft 114-a. In someembodiments, the transmission lines are electrical wires.

In some embodiments, the first shaft 112-a can be configured such thatit is capable of rotating independently of the second shaft 114-a. Thiscan be due at least in part to the break 140-a separating the firstshaft 112-a from the second shaft 114-a. In some embodiments, the secondshaft 114-a is coupled at a proximal end to the power source. The break140-a between the first shaft 112-a and the second shaft 114-a can helpto ensure that that the coupling between the power source and secondshaft 114-a does not impede the transmission of torque from the firstshaft 112-a to the expandable support device.

In some embodiments, the separation of the first shaft 112-a from thesecond shaft 114-a allows the first shaft 112-a to be configured fortransmitting torque to the expandable support member and any operativemember disposed thereon. In some embodiments, this is accomplished bycoupling at least a portion of the first shaft 112-a to at least aportion of the expandable support device and/or the transmission lines3105 so that rotation of the first shaft 112-a is transmitted to theexpandable support device and/or transmission lines 3105. When the firstshaft 112-a is coupled with the transmission line 3105, the transmissionlines 3105 can be coupled with the first shaft 112-a at the distal endof the first shaft 112-a while being decoupled with the first shaft112-a at the proximal end of the first shaft 112-a. This can help toensure that the first shaft 112-a is configured to transmit torque tothe expandable support device and/or the transmission lines 3105.

With reference to FIG. 18B, in some embodiments, the break 140-a can becovered by a protection element 165-a. The protection element 165-a canbe made of any suitable material and can have any shape and/or size thatallows it to cover the break 140-a and protect the transmission lines3105. As shown in FIG. 18B, the protection element 165-a can have agenerally cylindrical shape, although other shapes can be used. In someembodiments, the protection element 165-a is coupled with the firstshaft 112-a and is sufficiently long to extend over the break 140-a anda portion of the second shaft 114-a. In some embodiments, the protectionelement 165-a is decoupled from the second shaft 112-a so that the firstshaft 112-a can continue to rotate independently of the second shaft114-a. The coupling of the protection element 165-a to the first shaftcan allow the protection element to be configured to transmit rotationalmotion to the first shaft 112-a. In this manner, the protection element165-a can also serves as a torque handle that aids a user in rotatingthe first shaft 112-a to transmit torque to the expandable supportdevice.

FIG. 18B also shows a working channel 115-g into which the first shaft112-a can be inserted. In some embodiments, an expandable support devicelocated at the distal end of the first shaft 112-a is inserted into theworking channel 115-g in a collapsed configuration, and the guideassembly 110-h is used to move the expandable support device through theworking channel 115-g. In some embodiments, the first shaft 112-a willbe the predominant portion of the guide assembly 110-h that enters theworking channel 115-g. The protection element 165-a can serves as astopper which prevents further insertion of the guide assembly 110-cinto the working channel 115-g.

The first shaft 112-a can be made from a flexible material, which willallow the first shaft 112-a to move more readily through a workingchannel 115-g having tortuous path. In some embodiments, the flexiblematerial used for the first shaft 112-a is stainless steel, such as astainless steel cable material. In some embodiments, first shaft 112-aincludes two or more concentric layers, with each layer being made fromtwo or more stainless steel wires wound around a common axis.

FIG. 19A and/or FIG. 19B illustrate a guide assembly 110-i in accordancewith various embodiments. The guide assembly 110-i is similar in manyrespects to the guide assembly 110-h illustrated in FIGS. 18A and/or18B. The guide assembly 110-i can include a first shaft 112-b, a secondshaft 112-b, and a protection element 165-b located between the firstshaft 112-b and the second shaft 114-b. In some embodiments, the firstshaft 112-b is configured to extend through a working channel andtransmit torque to an expandable support device coupled with the distalend of the first shaft 112-b.

The protection element 165-b can be positioned between the first shaft112-b and second shaft 114-b. As shown in FIGS. 19A and 19B, theprotection element 165-b can include a knurled surface to aid inmanipulation by a user. First shaft 112-b can be configured to transmittorque applied to protection element 165-b to an expandable supportdevice to cause rotation. In various embodiments, the first shaft 112-bis configured to transmit up to 5 in.-oz. of torque, and preferably upto 9 in.-oz. of torque.

The second shaft 114-b can include a tubular body through which an oneor more transmission line can be routed to a power source 105-c. Thesecond shaft 114-b may also be configured for receiving otherconnections. The second shaft 114-b may be formed of plastic such asnylon, a thermoplastic elastomer such as Pebax® (polyether block amide),or polytetrafluoroethylene (PTFE). The second shaft 114-b can beelongated to allow the power source 105-c to be positioned remotely fromthe patient receiving treatment. In various embodiments, the first shaft112-b and the second shaft 114-b can be transparent to enable visualinspection by the user. For example, the internal components may includemarkers or indexes to enable the user to visually verify the axialposition of the expandable support device when it is inserted into thepatient's body.

In some embodiments, the transmission line and/or other internalcomponents extend through the entire guide assembly 110-i. In variousembodiments, the components are separated into two sections providedwith first shaft 112-b and second shaft 114-b alike.

In some embodiments, the second shaft 114-b is not attached to theinternal components such as the transmission wires. This can allow thesecond shaft 114-b to rotate independently of the internal components.In practice, the second shaft 114-b can be attached to a fixed devicelike the power source 105-c whereas the internal wires rotate with theexpandable support device. Thus, the second shaft 114-b can house thewires without twisting during operation. As may be appreciated by one ofskill in the art, the wires are capable of twisting to a larger degreethan the second shaft 114-b. This can allow the second shaft 114-b to berotated to a significant degree without buckling, crimping, or binding.

In some embodiments, the second shaft 114-b generally does not play arole in movement of the expandable support device at the distal end ofthe guide assembly 110-i. Instead, the second shaft 114-b is simply“along for the ride” to house the internal components. The second shaft114-b can be rigid or flexible.

First shaft 112-b can be configured to transmit torque to the expandablesupport device to cause rotation. The first shaft 112-b can besufficiently flexible to allow it to move through a tortuous workingchannel, but can also have sufficient rigidity to transmit axial forceto the expandable support device. Torque from the protection element165-b can be transmitted through the first shaft 112-b to the expandablesupport device thereby causing rotation of the expandable supportdevice. Similarly, an axial force on the protection element 165-b cancause the first shaft 112-b to push on the expandable support device andmove it axially.

The first shaft 112-b can be coupled with expandable support device at adistal end and a protection element 165-b at a proximal end. In someembodiments, the first shaft 112-b also includes a rigid section 3205 atthe proximal end. In some embodiments, the rigid section 3205 can serveas a fastener between the protection element 165-b and the first shaft112-b. The rigid section 3205 can connect the first shaft 112-b to theprotection element 112-b rotationally and axially. In some embodiments,rigid section 3205 is a stainless steel hypotube connected to theprotection element 165-b. The rigid section 3205 can be crimped to fixthe protection element 165-b to the first shaft 112-b. The rigid section3205 can maintain the alignment of the guide assembly 110-i in theproximal end of a working channel and ensures good torque transfer fromthe protection element 165-b to the first shaft 112-b. The rigid section3205 can be configured to be inserted into a working channel. In someembodiments, the rigid section 3205 has a length of about 2 cm. When therigid section 3205 is included, the first shaft 112-b can be consideredto include a rigid section 3205 and a flexible section, with theflexible section being positioned between the expandable support devicehaving an operative member disposed thereon and the rigid section 3205.An introducer may also be used in conjunction with the rigid section3205 to aid in alignment and movement within the working channel.

Unlike second shaft 114-b, first shaft 112-b can be rotationally fixedto the transmission wires and the protection element 165-b. In otherwords, rotation of protection element 165-b can cause the first shaft112-b to rotate which in turn causes the expandable support device torotate. At the same time, the wires can rotate based on rotation of theexpandable support device. However, second shaft 114-b can remain fixedto the generator while the wires twist internally in some cases. Thus,the first shaft 112-b can be torqueable with the protection element165-b but the second shaft 114-b is not. Put another way, the firstshaft 112-b and the second shaft 114-b can be rotationally decoupledfrom each other.

The transmission lines extending through the first shaft 112-b and thesecond shaft 114-b can be relatively flexible. In some embodiments, thetransmission lines are generally not at risk of kinking when the firstshaft 112-b is rotated. The transmission lines can simply twist and turninside the second shaft 114-b. In some embodiments where thetransmission lines are only fixed to a distal end of the first shaft112-b, the transmission lines may be free to also rotate within thefirst shaft 112-b.

In various embodiments, guide assembly 110-i is configured to reducetorquing and twisting of the transmission line. The transmission linesmay include a proximal end and a distal end that are decoupled from eachother. For example, protection element 165-b may include a mechanicaldevice for decoupling rotation of the transmission wires extendingdistally from the protection element 165-b from the transmission wiresat the proximal end. Suitable devices for decoupling rotation of thetransmission wires include, but are not limited to, a bearing, abushing, a stator and core assembly, and the like.

In various embodiments, protection element 165-b is configured as aquick connector. As may be understood by one of skill from thedescription herein, the first shaft 112-b and the second shaft 114-b canbe configured as independent assemblies, each with their own set oftransmission lines. Thus, the protection element 165-b can be configuredto easily connect and disconnect to the first shaft 112-b and the secondshaft 114-b. This may beneficially improve ease-of-use during surgery.In various embodiments, the first shaft 112-b is disposable and thesecond shaft 114-b can be re-used.

Suitable materials for the first shaft 112-b include, but are notlimited to, thermoplastics and stainless steel. In various embodiments,the first shaft 112-b is Nylon 12 with a 0.002″×0.005″ stainless steelbraid. In various embodiments, the first shaft 112-b is a 0.002″×0.005″tube formed of Pebax®. In some embodiments, the first shaft 112-b ismade of a stainless steel coil shaft. The protection element 165-b maybe formed of thermoplastics such as acrylonitrile butadiene styrene(ABS) and other materials. In various embodiments, the second shaft112-b includes a lubricious liner (e.g. PTFE or FEP) to aid withassembly and rotation of the transmission lines. In various embodiments,transmission lines are a bundle of one or more conductive wires.

In some embodiments, the guide assembly further includes a handleelement. The handle element can be coupled with a first shaft to assistin transmitting torque to the expandable support device and/or to movethe expandable support device in an axial direction. In someembodiments, the handle element includes a body and a channel extendingthrough the body. The first shaft can pass through the channel tothereby couple the handle element to the first shaft. In someembodiments, the handle element is configured such that the first shaftcan move through the channel. The handle element can also include arigid section extending off a distal end of the handle element throughwhich the first shaft can also pass. The rigid section on the handleelement can be similar in many respect to the rigid section 3205described above. The rigid section extending from the distal end of thehandle element can be at least 2 cm long and can be configured forinsertion into a working channel.

In some embodiments, the handle element is positioned at the proximalend of the first shaft. The handle element can be configured to extendover a portion of the second shaft so that it serves as a protectionelement for any transmission wires that may be exposed due to a breakbetween the first shaft and the second shaft.

With reference to FIG. 20, a handle element 3305 is shown in accordancewith various embodiments. The handle element 3305 can have a generallyelongate shape and can be coupled with a first shaft 112-c by virtue ofthe first shaft 112-c passing through a channel in the body of thehandle element 3305. The handle element 3305 can be configured to slidealong the first shaft 112-c. In some embodiments, the handle elementincludes a locking mechanism 3310. The locking mechanism 3310 can beconfigured to lock the handle element 3305 at a position along thelength of the first shaft 112-c. This can be achieved using any suitablelocking mechanism 3310. In some embodiments, the locking mechanism 3310is fixed to the handle element 3305 such that when the locking mechanism3310 is engaged against the first shaft 112-c (for example, by screwingthe locking mechanism 3310 down against first shaft 112-c until thefirst shaft 112-c is pinched between the locking mechanism 3310 and thehandle element 3305), the handle element 3305 is locked into position byvirtue of being fixed to the locking mechanism 3310.

In some embodiments, the handle element 3305 is provided to control thelength of the first shaft 112-c that can be inserted into a workingchannel. The handle element 3305 can serve as a stopper. When the handleelement 3305 is moved towards the distal end of the first shaft 112-cand is locked in place, the handle element 3305 can shorten the amountof first shaft 112-c that can pass into the working channel. When thehandle element 3305 is moved towards the proximal end of the first shaft112-c, the handle element 3305 can increase the amount of first shaft112-c that can pass into the working channel. In operation, apractitioner can insert the expandable support and the first shaft 112-cinto a working channel until the expandable support device emerges fromthe distal end of the working channel and is brought close to the targettreatment area. The handle element 3305 can then slide along the firstshaft 112-c towards the distal end until the handle element 3305 restsagainst entry of the working channel. By locking the handle element 3305in place at that position, the practitioner can effectively set thelength of the first shaft 112-c and ensure that the expandable supportdevice will stay in the desired location near the target area so long asthe handle element 3305 is resting against the working channel entry.

FIG. 20 shows that the handle element 3305 can also include a rigidsection 3205-a at the distal end that is configured to be inserted intoa working channel and help align the handle element 3305. The rigidsection 3205-a may be similar or identical to the rigid section 3205described above. FIG. 20 also shows that the handle element 3205 can beused in a conjunction with a protection element 165-c. The protectionelement 165-c can be similar or identical to the protection element165-b described above. The protection element 165-c can be coupled withthe first shaft 112-c and can extend over a portion of the second shaft114-c to protect exposed transmission lines at the break. The protectionelement 165-c can also be provided to prevent the handle element 3305from sliding over the second shaft 114-c.

With reference to FIG. 21, a handle element 3405 in accordance withvarious embodiments is shown. The handle element 3405 can have agenerally elongate shape and can be coupled with a first shaft 112-d byvirtue of the first shaft 112-d passing through a channel in the body ofthe handle element 3405. The handle 3405 can include an axial path 3410along which a locking mechanism 3415 can slide towards the distal orproximal end of the handle element 3405. The locking mechanism 3415 canbe configured to be secured to a portion of first shaft 112-d locatedwithin the channel of the handle element 3405. The locking mechanism canalso be locked in place anywhere along the axial path 3410. Accordingly,when in an unlocked position, the locking mechanism 3415 can move alongthe axial path 3410, but when in the locked position, the lockingmechanism 3415 is fixed to the handle element 3405 and cannot slidealong the axial path 3410.

Whether in a locked or unlocked position, the locking mechanism 3405 canremain secured to a portion of the first shaft 112-d. In this manner,the locking mechanism can move the first shaft 112-d in and out of thehandle element 3405 when in the unlocked position, and can hold thefirst shaft 112-d in place when in the locked position. Thus, the handle3405 is configured to adjust and control the amount of first shaft 112-dextending out of the handle element 3405 and, correspondingly, thelength of the first shaft 112-d that can be fed through the workingchannel. For example, when the handle element 3405 is positioned againstthe entry of the working channel, the locking mechanism 3415 can bemoved towards the proximal end of the handle element 3405 to shorten thelength of the first shaft 112-d and pull the expandable support memberback towards the working channel. The locking mechanism 3415 can also bemoved towards distal end of the handle element 3405 to increase thelength of the first shaft 112-d and move the expandable support membercloser to the target treatment area. Once a desired position is achievedfor the expandable support device, the locking mechanism 3415 can belocked against the handle element 3405 to fix the position of theexpandable support device.

In some embodiments, the guide assembly is coupled with the expandablesupport device using a torque member. The torque member can be astructure located at the distal end of the first shaft, a structurelocated at a proximal end of the expandable support device, or acombination of the two. The torque member is generally configured toensure that torque generated by rotation of first shaft is transmittedto expandable support device. In some embodiments, the guide assemblyand/or the torque member are configured such that approximately one toone rotation movement is achieved between the guide assembly and thetorque member.

With reference to FIG. 22, a distal plug 3505 in accordance with variousembodiments is shown. The distal plug 3505 may include a structureprotruding from the proximal end of the expandable support device 120-s.The distal plug 3505 can include a ribbed portion which is inserted intothe distal end of the first shaft of the guide assembly. The distal plug3505 also may include a cone shaped section 3510 that creates a faceedge 3515. This face edge 3515 can rest against the distal edge of thefirst shaft and is configured to be wider than the diameter of thedistal end of the first shaft so that the cone shaped section 3510cannot be inserted into the first shaft. The distal plug 3505 may besecured within the first shaft by conventional techniques such as glue,adhesives, or interference fit.

FIG. 23 shows a torque member 3605 in accordance with variousembodiments. The torque member 3605 may be configured for transmittingtorque between the guide assembly and a locking member extending from adistal end of an expandable support device. The torque member 3605 canbe rigid for enabling application of torque to rotate the expandablesupport device. The torque member 3605 may include a solid, rigid bodyand a slot 3610. The slot 3610 may have a thickness corresponding to thethickness of a locking member extending from a distal end of the anexpandable support device such that the locking member can be securelyreceived within the slot. In various embodiments, the torque member 3605can have a width equal to or less than the diameter of the guideassembly at a distal end. The torque member 3605 can have a thicknessslightly less than a width of the guide assembly at the distal end.Similarly, the locking member can have a thickness equal to or less thana width/diameter of the working channel. In this manner, the lockingmember may not need to fold or collapse during withdrawal and can berelatively rigid to enable torque transmission. As used herein,“thickness” refers to a direction into the page and “width” refers to adirection from left to right.

FIG. 24A and/or FIG. 24B show another torque member 3705 in accordancewith various embodiments, which is configured for transmitting torquebetween the guide assembly and a locking member extending from aproximal end of an expandable support device. The torque member 3705 canbe formed of a rigid material such as a thermoplastic. In someembodiments, the torque member is formed of polycarbonate.

The torque member 3705 can include a body 3710 having a proximal end3715 and distal end 3720. The torque member 3705 can be shaped like apeg or a rod with a rounded surface along its length.

Distal end 3720 may be enlarged and may define a fitting portion 3725 ofthe torque member 3705. The fitting portion 3725 can extend from thedistal end 3720 to a point between the distal end 3720 and proximal end3715. The fitting portion 3725 can have a beveled outer surface with adistal edge having a smaller diameter than a proximal edge. The proximaledge of the fitting portion 3725 can include a breaking edge 3730 and aflat surface 3735. The fitting portion 3725 can be configured to beinserted into distal end of a first (i.e., distal) shaft such thatbreaking edge 3730 abuts a distal end of a first shaft. In variousembodiments, the body 3710 has a shape and dimensions corresponding tothe inner wall of the first shaft. In some embodiments, the distal andproximal edges of fitting portion 3725 are rounded to reduce the risk ofdamage, such as perforating, other components. The torque member 3705may be secured within the first shaft by conventional techniques such asglue, adhesives, or interference fit.

The torque member 3705 can include a slot 3740 that extends the entirelength of the torque member 3705. In various embodiments, the torquemember 3705 has a length corresponding to the length of a locking memberextending from the distal end of an expandable support device. The slot3740 can have a width that corresponds to a width of the locking member.The width of the slot 3740 can be less than a width of the torque member3705. The slot 3740 may be positioned at a distance above a centerlineof the torque member 3705.

In some embodiments, the torque member 3705 has a length of about 0.2inch. The torque member 3705 can have a width (diameter) of about 0.072inch, and the fitting portion 3725 can have a maximum width (diameter)of about 0.09 inch. The beveled face of fitting portion 3725 can form anangle of about 15° from a longitudinal axis of the torque member 3705.The fitting portion 3725 can extend from an end of the torque member3705 and have a length of about 0.039 inch. The slot 3740 can have awidth of about 0.056 inch. A bottom of the slot 3740 can be positionedabout 0.011 inch above a centerline of the torque member 3705. Otherembodiments may include different dimensions.

The slot 3740 can be configured to allow interlocking of the torquemember 3705 with a locking member extending from a distal end of aexpandable support device. Referring to FIG. 12A, a locking member 1280in accordance with various embodiments is illustrated. A throat section1285 of the locking member 1280 can be held within the slot 3740 andlocking section 1290 can be locked against a proximal end 3715 of thetorque member 3705.

With reference to FIG. 25A and/or FIG. 25B, an introducer 2605 can beused in order to aid with the introduction of an expandable supportdevice into a working channel, such as an endoscope. The introducer 2605can include a conical section 2610 and a cylindrical section 2615, witha channel extending through both sections. The cylindrical section 2615can have a uniform outer diameter which can be less than the diameter ofan opening of a working channel such that the cylindrical section 2615can be inserted into the opening of the working channel. In someembodiments, the outer diameter of the cylindrical section 2615 issmaller than the diameter of the working channel opening by only a smalldegree such that the cylindrical section 2615 fits flushly with theopening of the working channel when inserted in the working channelopening. The conical section 2610 can have a first diameter and a seconddiameter. The first diameter can be approximately the same as thediameter of the cylindrical section 2615. The second diameter can belarger than the first diameter, and the diameter of the conical section2610 can increase from the first diameter to the second diameter tothereby form a cone shape. In some embodiments, the cylindrical section2615 and the conical section 2610 are coaxially aligned.

When inserted in the working channel opening, the introducer 2605 canprovide a wide mouth for inserting an expandable support device into aworking channel. More specifically, the second diameter of the conicalsection 2610 can provide a wider area than the opening of the workingchannel to thereby make it easier for an operator to guide an expandablesupport device into a working channel.

In some embodiments, the introducer 2605 can be used in conjunction withan docking member 2620. In some embodiments, the docking member 2620 ispart of a a control element and/or protection element, such asprotection element 165 of FIG. 1B. In some embodiments, the dockingmember 2620 is a separate device from the protection element, but can becoupled with the protection element. The docking member 2620 can have afirst end 2625 and a second end 2630, with a channel extending throughthe docking member 2620 from the first end 2625 to the second end 2630.The first end 2625 can include a coupling mechanism configured forcoupling the introducer 2605 with the docking member 2620. In someembodiments, the second diameter of the conical section 2610 includes acoupling mechanism that mates with the coupling mechanism on the firstend 2625 of the docking member 2620. Any suitable coupling mechanism canbe used to couple the introducer 2605 to the docking member 2620,including, but not limited to, a friction fit, male and femalethreading, or clips as shown in FIG. 25A. With reference to FIG. 25B,the introducer 2605 is shown coupled with the docking member 2620.

With reference to FIG. 26A and/or FIG. 26B, the docking member 2605forms a part of the protection element 165-d such that the dockingmember 2605 and the protection element 165-d are a unitary body. Thedocking member 2605 can form the distal end of the protection element165-d and can provide the protection element 165-d with the couplingmechanism used to couple the introducer 2605 to the protection element165-d. As shown in FIG. 26A, the introducer 2605 can be inserted into anopening of a working channel 115-h and used to aid in the insertion ofan expandable support device into the working channel 115-h. As shown inFIG. 26A, an expandable support device has been inserted into theworking channel 115-h and a portion of the guide assembly 110-j remainsoutside of the working channel 115-h.

With reference to FIG. 26B, the introducer 2605 can be moved away fromthe working channel 115-h and towards the docking member 2620 of theprotection element 165-d. The introducer 2605 generally slides along theguide assembly 110-j by virtue of the guide assembly 110-j passingthrough the channel of the introducer 2605. When the introducer 2605reaches the docking member 2620 of the protection element 165-d, thecoupling mechanism of each device can be used to couple the introducer2605 to the protection element 165-d. In this manner, the introducer2605 can be fixed to a location along the guide assembly 110-j andprevented from sliding back and forth along the guide assembly 110-j dueto the protection element 165-d being fixed to the guide assembly110-jas described in greater detail above. As a result, the introducer2605 may not disturb the operator or interfere with manipulation of theexpandable support device via the guide assembly 110-j and/or theprotection element 165-d.

The manner in which the above described components of the treatmentsystem are manufactured is generally not limited. With reference toFIGS. 27A-F, a method of constructing an operative member on anexpandable support device and attaching the expandable support device toa flexible support in accordance with various embodiments is shown. InFIG. 27A, an expandable support device 120-t, such as a solidelastomeric body in the shape of a paddle is provided. In FIG. 27B, alayer of metallic layer 2705 is disposed on top of the expandablesupport device using any known technique. As shown in FIG. 27C, themetallic layer 2705 is then etched to form an operative member 160-e(for example, a pattern of electrodes) using any known technique, suchas etching using masks. In FIG. 27D, a flexible support 155-n isprovided, such as a nitinol flexible support. In FIG. 27E, an adhesive2710, such as a silicone adhesive, is provided on a surface of theflexible support 155-n. In FIG. 27F, the combination of the expandablesupport device 120-t and the operative member 160-e is disposed on theadhesive 2710, and time and/or pressure is supplied to secure thecombination of the expandable support device 120-t and the operativemember 160-e to the flexible support 155-n. Other methods ofconstructing an operative member may also be utilized in someembodiments.

FIGS. 28A-28E are sequential views of a method of fabricating apatterned solid support and providing an operative member on top of thepatterned solid support in accordance with various embodiments. FIG. 28Ashows a solid support material 2805 for forming a patterned solidsupport in accordance with various embodiments. The solid supportmaterial 2805 can be a solid layer of material formed from a shapememory metal alloy such as nitinol. The solid support material 2805 maybe formed into a thin, generally planar sheet using known processes suchas cutting and rolling.

Next, solid support material 2805 is patterned using techniques to formpatterned solid support 1605-1 as shown in FIG. 28B in accordance withvarious embodiments. Examples of suitable patterning techniques includewet and dry etching, lithography, deposition, cutting, and milling. Thepatterning may define splines in the patterned solid support 1605-1. Thepatterning may be performed simultaneously with the rolling.

Next, the operative member is formed as shown in FIGS. 28C and 28D. Insome embodiments, the operative member is a flexible circuit with RFelectrodes. With reference to FIG. 28C, an insulator material 2405-a maybe formed using conventional techniques. The exemplary insulatormaterial 2405-a may be formed of a 0.001 inch adhesiveless polyimidesheet.

As shown in FIG. 28D, conductor material may then be added to theinsulator material 2405-a and etched to form an operative member 160-fof electrodes. In this step, an adhesive 2815 can also applied to a backside to the insulator material 2405-a. For example, a thin acrylicand/or silicone sheet adhesive 2815 may be applied to the back of theinsulator material 2405-a. In an exemplary embodiment, the pattern orelectrodes is formed by laser etching.

FIG. 28E shows the assembled operative member 160-f and patterned solidsupport 1605-1 in accordance with various embodiments. As shown in 18E,the electrodes of the operative member 160-f may be positioned oversplines of the patterned solid support 1605-1. FIG. 28E may be asimplified and exaggerated view of the patterned solid support 1605-1and operative member 160-f. In practice, for example, the relativethicknesses of the layers will vary. Other embodiments may be utilizedin fabricating a patterned solid support and providing an operativemember on top of the patterned solid support.

One will appreciate from the description herein that other processes maybe used in the fabrication process. For example, the fabrication processmay include one or more coating processes. For example, the any portionof the operative member may be coated with a material such as abioactive agent. In various embodiments, the expandable support deviceis coated with a biomolecule such as a pharmaceutical agent, nucleicacid, amino acid, sugar, or lipid. In various embodiments, theexpandable support device is coated with an antihyperplastic agent suchas an antithrombotic agent (e.g. heparin), an antiplatelet agents (e.g.aspirin, arachidonic acid, and prostacyclin), or an antibody toplatelet-derived growth factors. Other suitable biological coatingmaterials and additives include endothelial cells, stem cells, and cellgrowth factors. In various embodiments, the operative member is coatedwith a biocompatible plastic such as polytetrafluoroethylene (PTFE),expanded PTFE (ePTFE), polypropylene, or poly(lactide). In variousembodiments, the coating is only applied to the expandable supportdevice so as not to interfere with functioning of the operative member.The expandable support device may be coated with a protective layer atany step in the process. For example, the expandable support device maybe coated with a barrier layer to prevent oxidation or bioabsorption.

The fabrication process may also include other steps such as polishing,thermal treatments, and the like. The method of assembling the ablationdevice may implement other techniques and processes common in thematerial science, computer, and semiconductor fields. In someembodiments, the operative member is applied directly to the expandablesupport device via a conductive paint, molding, or laser etching.

Various embodiments of the systems described herein, including variousembodiments of the individual components, can be used in a variety ofways. An embodiment of a particular method is described below.

In a first step, a clinician may perform a general clinical assessment.This assessment may include assessing the disease target, the type ofnecessary treatment, and the mode of delivery of the treatment device.Based on the clinical assessment, the clinician may select a propertreatment device. For example, a kit may be provided with multipleoperative members configured for different treatments. The kit mayinclude multiple ablation devices, each with differently-sized treatmentsurfaces, electrode configurations, treatment modalities, etc. Theclinician may select a larger ablation device from the kit if thedisease target is large. The kit may include an ablation device fortreating larger or smaller circumferential sections of the body lumen,for example, a 90 degree section or a 120 degree section.

Once the operative member has been selected, the clinician may assemblethe system. In one example, the kit includes a guide assembly, andmultiple expandable support devices having varying operative membersdisposed thereon. The clinician may slide the selected expandablesupport device onto a distal end of the guide assembly and secures it inplace. In another example, the kit may include multiple pre-assembledsystems, each with a guide assembly and an attached expandable supportdevice-operative member combo. In yet another example, the system mayinclude an expandable support-operative member combo configured fortreating a variety of disease targets (e.g. one-size-fits-all).

Once the system is prepared, the clinician may insert the expandablesupport device-operative member combo through a cap at a proximal end ofa working channel, such as an endoscope. At this stage the endoscope maybe already inserted and positioned in the patient's body. Typically thedistal end of the endoscope is positioned adjacent a target site usingconventional techniques.

The expandable support device-operative member combo may be inserteddistal end first. The expandable support device-operative member combocan be pre-biased in the expanded configuration, in which case it mayneed to be collapsed to fit into the smaller working channel. Theclinician may gently squeeze the expandable support device-operativemember combo to collapse it for insertion. An introducer may be utilizedin some cases. The rounded distal tip of the expandable supportdevice-operative member combo may aid in rolling the device into theworking channel. Once the distal end of the expandable supportdevice-operative member combo is inserted, the clinician eases the restof the expandable support device-operative member combo into the workingchannel.

Next, the clinician may push the expandable support device-operativemember combo through working channel in the collapsed configurationusing guide assembly. The clinician can axially move the expandablesupport device-operative member combo through the channel like a pipecleaner using the guide assembly.

The length of the guide assembly may be matched to the length of theendoscope such that a protection element or handle element is locatedjust proximal the endoscope cap at the entry of the endoscope when theexpandable support device-operative member combo is fully inserted. Theclinician may use an introducer to assist with insertion. The protectionor handle element can be larger than the endoscope working channel andthus acts as an insertion stop. The protection or handle element canalso act as a visual clue to the user of the expandable supportdevice-operative member combo position at an opposite end. As theprotection or handle element approaches the cap of the endoscope, theuser can gauge the position of the expandable support device-operativemember combo relative to the distal most end of the endoscope.

The guide assembly may be oversized to accommodate insertion into avariety of endoscopes and other delivery lumens. In various embodiments,exemplary an elongated rigid portion extending off the distal end of aprotection or handle element can be used for axial positioningadjustment with various working channel lengths. As the user pushes andpulls the protection or handle element, the rigid section may remainpositioned in the working channel. The rigidity of rigid section canallow for easier axial movement without binding the guide assembly onthe inner wall of the working channel.

The system may be configured for use with a variety of lumens andtreatment sites including, but not limited to, the gastrointestinaltract (GI tract), respiratory tract, ear canal, urinary tract, biliarysystem and bile duct, female reproductive system, organs in the chest(e.g., heart), epidural space, maxillary and face, and hand. The systemmay be configured for a variety of therapies and procedures using anendoscope including, but not limited to, esophagogastroduodenoscopy(e.g., esophagus, stomach, and duodenum); enteroscopy (e.g., smallintestine); colonoscopy or sigmoidoscopy (e.g., large intestine andcolon); magnification endoscopy; endoscopic retrogradecholangiopancreatography (ERCP), duodenoscope-assistedcholangiopancreatoscopy, or intraoperative cholangioscopy (e.g., bileduct); rhinoscopy (e.g., nose); bronchoscopy (e.g., lower respiratorytract); cystoscopy (e.g. urinary tract); rectoscopy (e.g. rectum);anoscopy (e.g., anus); proctoscopy; plastic surgery; orthopedic surgery(e.g., hand surgery like endoscopic carpal tunnel syndrome and epiduralspace); endodontic surgery; gynoscopy, colposcopy (e.g., cervix),hysteroscopy (e.g., uterus), and falloscopy (e.g. fallopian tubes);laparoscopy; arthroscopy (e.g., interior of a joint); thoracoscopy andmediastinoscopy; amnioscopy; and fetoscopy. The system may be configuredfor a variety of therapies and procedures using other instrumentsincluding, but not limited to, dialysis, catheterization, angioplasty,balloon-based procedures (e.g., balloon septostomy and balloonsinuplasty), electrophysiology, monitoring (e.g., cardiac monitoring),drug delivery, and ear wax removal and treatment of cerumen impaction.

The endoscope, or other device that includes a working channel such as acatheter, can be inserted into the body using conventional techniques.For example, the endoscope may be inserted through a body orifice orthrough an incision site (e.g., laparoscopy). As may be appreciated fromthe description herein, the system may be used in conjunction with otherinstruments having a lumen such as a catheter, a robotic surgicalinstrument, and more.

Typically the working channel may be routed through a body cavity, duct,or vessel to a treatment site. The clinician optionally confirms theworking channel distal end is properly positioned at the treatment sitebefore deploying expandable support device-operative member combo. Oncethe position is confirmed, the clinician may proceed to deploy theexpandable support device-operative member combo.

The system can allow for easy and accurate deployment of the expandablesupport device-operative member combo. The clinician may axially movethe protection or handle element so expandable support device-operativemember combo is moved out of a distal end of working channel. As theexpandable support device-operative member combo extends outside theworking channel, the expandable support device-operative member combomay be released from the working channel wall. The expandable supportdevice-operative member combo self-expands from the collapsedconfiguration to the expanded configuration without any othersignificant action on the part of the clinician. The clinician may onlyneed to move the protection or handle element close to the cap to ensurethe expandable support device-operative member combo has been deployedat the distal end. The natural “spring” force of the expandable supportdevice against the channel wall may also provide haptic feedback to theuser to confirm deployment.

In various embodiments, the expandable support device-operative membercombo is configured to self-expand to the expanded configuration once itunrestrained. In various embodiments, the expandable supportdevice-operative member combo is substantially planar in the expandedconfiguration. In various embodiments, the plane of the expandedexpandable support device-operative member combo is substantiallyparallel to the target treatment surface. In various embodiments, theplane of the expanded expandable support device-operative member combois substantially parallel to the longitudinal axis of the guideassembly.

The torqueable guide assembly may allow the expandable supportdevice-operative member combo to be rotated during or after expansion.The user can easily rotate the expandable support device-operativemember combo by rotating, for example, the protection or handle element.Because first shaft is rotationally decoupled from second shaft, theexpandable support device-operative member combo can be rotatedindependently of the second shaft. In an exemplary embodiment, thesecond shaft is attached to a stationary power source and control unit.Thus, the expandable support device-operative member combo can berotated without developing kinks and rotational stress.

In various embodiments, after expansion, the user rotates the expandablesupport device-operative member combo so the treatment surface faces thetissue surface. The protection or handle element also allows a user torotate the expandable support device-operative member combo aftertreatment to treatment other areas of tissue. The user may affectdesired contact of expandable support device-operative member combo withthe treatment site by deflecting the distal end of endoscope. The usermay affect contact by deflecting the expandable support device-operativemember combo using guide assembly. For example, the protection or handleelement may be manipulated to extend the expandable supportdevice-operative member combo away from an end of the endoscope andtoward the treatment site.

Once the expandable support device-operative member combo is positionedat treatment site, the clinician can administer treatment using theexpandable support device-operative member combo. The clinician mayactivate the power source to deliver energy through the operative member(such as through electrodes). In various embodiments, the power sourceperforms a pre-programmed treatment protocol. In various embodiments,the power source is manually controlled.

After energy delivery, the clinician may determine whether follow-uptreatment is necessary. If so, the treatment site can be prepared forfollow-on treatment. For example, the treated tissue can be cleaned awaywith a cleaning device. The cleaning device may comprise a cleanerattached to the expandable support device-operative member combo. Anexample of a cleaning device for use with an expandable supportdevice-operative member combo is disclosed in U.S. Patent Pub. No.2009/0036886 to Utley et al., the entire contents of which isincorporated herein by reference for all purposes.

After treatment is complete, the clinician may pull on protection orhandle element to retract the expandable support device-operative membercombo. As the expandable support device-operative member combo iswithdrawn, a portion of a tapered edge of expandable supportdevice-operative member combo may contact the working channel. As theexpandable support device-operative member combo is withdrawn further,the tapered edge may slide against the working channel wall such that acollapsing or rolling force is applied to the expandable support device.This force may cause the expandable support device, and consequently theoperative member disposed thereon, to retract back into the collapsedconfiguration as it is pulled into the working channel.

The fully retracted expandable support device-operative member combo canbe repositioned safely while in the working channel. The expandablesupport device-operative member combo device can then be repositioned ata second treatment location using the endoscope. Once the endoscope isrepositioned, the expandable support device-operative member combo maybe re-expanded out of an end of the endoscope as described above.

Alternatively, the expandable support device-operative member combo canbe repositioned through the working channel. For example, the cliniciancan move the expandable support device-operative member combo axiallyand/or rotate the expandable support device-operative member combo usingprotection or handle element. When treatment is complete, the expandablesupport device-operative member combo can be fully retracted and removedfrom the proximal end of the endoscope.

With reference to FIG. 29, a general method 2900 of using variousembodiments of the systems and/or devices described herein is shown inaccordance with various embodiments. For example, method 2900 may beimplemented utilizing the various embodiments of system 100, expandablesupport element 120, guide assembly 110, operative member 160, and/orother devices and/or components. At block 2905, a therapy system isprovided. The system can include any embodiments of the therapy systemdescribed herein, including any embodiment of the individual componentsof the system described herein. Generally, the system will include anexpandable support device, optionally with an operative member disposedthereon, a guide assembly to which the expandable support device iscoupled at a distal end of the guide assembly, and a working channelconfigured for receiving the expandable support device and the guideassembly.

At block 2910, the expandable support device is inserted into a firstend of the working channel. In some embodiments, the expandable supportdevice is positioned in a collapsed position prior to inserting theexpandable support device into the working channel. The distal end ofthe expandable support device can be rounded for further aid in theinsertion of the expandable support device into the working channel.

At block 2915, the expandable support device is moved through theworking channel until the expandable support device emerges out of asecond end of the working channel. The guide assembly can be used to aidin the movement of the expandable support device through the workingchannel and out of the second end of the working channel. In someembodiments, the expandable support device will self transition into anexpanded configuration after it passes out of the second end of theworking channel.

After the expandable support device passes out of the working channel,an optional step can be performed wherein a portion of the guideassembly is rotated to provide torque to the expandable support device.In some embodiments, the first shaft portion of the guide assembly isrotated to provide torque to the expandable support device. The firstshaft can be rotationally independent of the second shaft.

Other additional steps that can be performed after the methodillustrated in FIG. 29 or any of the methods illustrated in FIGS. 30,31, 32, 33, 34, and/or 35 can include deflecting the working channel andbringing the expandable support device (which may have an operativemember disposed thereon) into contact with a target treatment areaand/or providing an apposition force via the expandable support device(and optionally the flexible support coupled with the expandable supportdevice), and/or delivering energy to the target treatment area. Othersteps may also be utilized in accordance with various embodiments.

With reference to FIG. 30 a general method 2900 of using variousembodiments of the systems and/or devices described herein is shown inaccordance with various embodiments. For example, method 3000 may beimplemented utilizing the various embodiments of system 100, expandablesupport element 120, guide assembly 110, operative member 160, and/orother devices and/or components. Method 3000 may provide for deliveringan expandable support device to a target treatment area. Method 3000 maybe an example of method 2900 of FIG. 29.

At block 3005, an expandable support device configured for delivering anoperative member through a working channel to a target treatment areamay be provided. The expandable support device may include anelastomeric body configured to support an operative member. Theelastomeric body may include: a proximal portion configured for couplingthe elastomeric body with a guide assembly; a distal portion oppositethe proximal portion; and a central axis extending between the distalportion and the proximal portion of the elastomeric body. The expandablesupport device may include one or more supports coupled with theelastomeric body and aligned parallel to the central axis, where atleast one of the supports includes a superelastic material.

At block 3010, the expandable support device may be inserted into afirst end of the working channel. At block 3015, the expandable supportdevice may be moved through the working channel until the expandablesupport device passes out of a second end of the working channel.

Some embodiments of method 3000 may include a block 3020 where theexpandable support device is torque and/or rotated utilizing the guideassembly. Some embodiments include positioning the expandable supportdevice into a collapsed position prior to inserting the expandablesupport device into the working channel.

With reference to FIG. 31 a general method 3100 of using variousembodiments of the systems and/or devices described herein is shown inaccordance with various embodiments. For example, method 3100 may beimplemented utilizing the various embodiments of system 100, expandablesupport element 120, guide assembly 110, operative member 160, and/orother devices and/or components. Method 3100 may provide for utilizing aguide assembly for delivering an operative member to a target treatment.Method 3100 may be an example of method 2900 of FIG. 29.

At block 3105, a system including a guide assembly may be provided. Theguide assembly may be configured for delivering and positioning theoperative member through a working channel to the target treatment area.The guide assembly may include: one or more transmission lines foroperatively connecting the operative member to a power source; a firstshaft enclosing at least a first portion of the one or more transmissionlines, the first shaft configured for transmitting torque to theoperative member; and a second shaft enclosing at least a second portionof the transmission lines. The first shaft and the second shaft may beconfigured to allow the first shaft to rotate independently of thesecond shaft. The system may include an expandable support deviceconfigured to deliver the operative member through the working channelto the target treatment area and coupled with a distal end of the guideassembly. The system may include an operative member coupled with theexpandable support device.

At block 3110, the expandable support device may be inserted into afirst end of the working channel. At block 3115, the expandable supportdevice may be moved through the working channel utilizing the guideassembly until the expandable support device passes out of a second endof the working channel. In some embodiments, the expandable supportdevice may be positioned into a collapsed position prior to insertingthe expandable support device into the working channel. Some embodimentsmay include a block 3120 that may include rotating the first shaft ofthe guide assembly to provide torque to the operative member.

With reference to FIG. 32, a general method 3200 of using variousembodiments of the systems and/or devices described herein is shown inaccordance with various embodiments. For example, method 3200 may beimplemented utilizing the various embodiments of system 100, expandablesupport element 120, guide assembly 110, operative member 160, and/orother devices and/or components. Method 3200 may deliver an operativemember to a target treatment area. Method 3200 may be an example ofmethod 2900 of FIG. 29.

At block 3205, a system may be provided that includes a guide assembly.The guide assembly may include: one or more transmission lines foroperatively connecting an operative member to a power source; a flexibleshaft enclosing at least a portion of the one or more power transmissionlines, the first shaft configured for transmitting torque to theoperative member; and a handle element comprising a body and a channelextending through the body and through which the flexible shaft passes,the handle element configured such that the flexible shaft moves throughthe channel. The system may also include an operative member coupledwith a distal end of the flexible shaft.

At block 3210, the operative member may be inserted into a first end ofa working channel. At block 3215, the operative member may be movedthrough the working channel until the operative member passes out of thesecond end of the working channel. At block 3220, the handle element maybe rotated to transmit torque to the operative member. Some embodimentsmay include positioning the operative member into a collapsed positionprior to inserting the operative member into the working channel.

With reference to FIG. 33, a general method 3300 of using variousembodiments of the systems and/or devices described herein is shown inaccordance with various embodiments. For example, method 3300 may beimplemented utilizing the various embodiments of system 100, expandablesupport element 120, guide assembly 110, operative member 160, and/orother devices and/or components. Method 3300 may deliver an ablationdevice to a target treatment area. Method 3300 may be an example ofmethod 2900 of FIG. 29.

At block 3305, an ablation device may be provided. The ablation devicemay include a flexible circuit configured to transition between acollapsed configuration and an expanded configuration. The flexiblecircuit may include multiple parallel electrodes configured to collapsearound an axis parallel to the multiple parallel electrodes.

At block 3310, the ablation device may be inserted into a first end of aworking channel. At block 3315, the ablation device may be moved throughthe working channel until the ablation device passes out of a second endof the working channel. Some embodiments of method 3300 includepositioning the flexible circuit into a collapsed configuration prior toinserting the ablation device into the working channel.

With reference to FIG. 34, a general method 3400 of using variousembodiments of the systems and/or devices described herein is shown inaccordance with various embodiments. For example, method 3400 may beimplemented utilizing the various embodiments of system 100, expandablesupport element 120, guide assembly 110, operative member 160, and/orother devices and/or components. Method 3400 may deliver an expandablesupport device to a target treatment area. Method 3400 may be an exampleof method 2900 of FIG. 29.

At block 3405, an expandable support device may be provided. Theexpandable support device may include: a solid support member comprisinga perimeter and superelastic properties; and multiple splines formed ina pattern interior to the perimeter of the solid support member andmultiple voids between adjacent splines. A width and a spacing of themultiple splines may be configured to promote expansion of the supportmember between a collapsed configuration and an expanded configurationproviding a substantially planar support surface.

At block 3410, the expandable support device may be inserted into afirst end of a working channel. At block 3415, the expandable supportdevice may be moved through the working channel until the expandablesupport device passes out of a second end of the working channel. Insome embodiments, the expandable support device is positioned into acollapsed configuration prior to inserting the expandable support deviceinto the working channel.

With reference to FIG. 35, a general method 3500 of using variousembodiments of the systems and/or devices described herein is shown inaccordance with various embodiments. For example, method 3500 may beimplemented utilizing the various embodiments of system 100, expandablesupport element 120, guide assembly 110, operative member 160, and/orother devices and/or components. Method 3500 may deliver an expandablesupport device to a target treatment area. Method 3500 may be an exampleof method 2900 of FIG. 29.

At block 3505, an expandable support device configured for deliverythrough a working channel to a target treatment area may be provided.The device may include: an expandable support member configured forsupporting an operative member, the support member comprising multiplesplines having a width and a spacing selected to promote expansion ofthe support member between a collapsed configuration and an expandedconfiguration. A portion of the support member may define asubstantially planar surface in the expanded configuration.

At block 3510, the expandable support device may be inserted into afirst end of the working channel. At block 3515, the expandable supportdevice may be moved through the working channel until the expandablesupport device passes out of a second end of the working channel. Someembodiments include positioning the expandable support device into acollapsed position prior to inserting the expandable support device intothe working channel.

The foregoing description provides examples, and is not intended tolimit the scope, applicability or configuration of the variousembodiments. Rather, the description and/or figures provide thoseskilled in the art with an enabling description for implementing variousembodiments. Various changes may be made in the function and arrangementof elements.

Thus, various embodiments may omit, substitute, or add variousprocedures or components as appropriate. For instance, it should beappreciated that the methods may be performed in an order different thanthat described, and that various steps may be added, omitted orcombined. Also, aspects and elements described with respect to certainembodiments may be combined in various other embodiments. It should alsobe appreciated that the following systems, methods, and devices, mayindividually or collectively be components of a larger system, whereinother procedures may take precedence over or otherwise modify theirapplication.

The foregoing descriptions of specific embodiments have been presentedfor purposes of illustration and description. They are not intended tobe exhaustive or to limit the invention to the precise forms disclosed,and obviously many modifications and variations are possible in light ofthe above teaching. The embodiments were chosen and described in orderto explain the principles of the various embodiments and its practicalapplication, to thereby enable others skilled in the art to utilize thevarious embodiments with various modifications as are suited to theparticular use contemplated. It is intended that the scope of thevarious embodiments be defined by the Claims appended hereto and theirequivalents.

1. An expandable support device configured for delivery through a working channel and to a target treatment area comprising: an expandable support member configured for supporting an operative member comprising a plurality of splines having a width and a spacing selected to promote expansion of the expandable support member between a collapsed configuration and an expanded configuration, wherein a portion of the expandable support member defines a surface in the expanded configuration.
 2. The device of claim 1, wherein the plurality of splines comprise: a central axis spline; a first subset of splines extending away from the central axis in a first direction; and a second subset of splines extending away from the central axis spline in a direction opposite the first direction.
 3. The device of claim 2, wherein the first subset of splines is arranged in parallel to one another and the second subset of splines is arranged in parallel to one another.
 4. The device of claim 3, wherein the first subset of splines and the second subset of splines extend away from the central axis spline at an angle such that the first and second subsets of splines extend from the central axis spline towards a distal end of the central axis spline.
 5. The device of claim 4, wherein the first subset of splines and the second subset of splines extend away from the central axis spline at an angle in the range of from greater than 0 degrees to 90 degrees.
 6. The device of claim 4, wherein the first subset of splines and the second subset of splines extend away from the central axis spline at an angle of about 45 degrees.
 7. The device of claim 2, wherein the first subset of splines and the second subset of splines have a thickness less than a thickness of the central axis spline.
 8. The device of claim 1, wherein the plurality of splines comprise nitinol.
 9. The device of claim 1, wherein the plurality of splines comprise: a central axis spline; a plurality of secondary splines arranged in parallel to the central axis spline, equally spaced apart from one another, and on either side of the central axis spline; a plurality of interconnecting splines arranged transverse to the secondary splines and interconnecting the secondary splines.
 10. A system for providing treatment to a target treatment area comprising: an expandable support member configured for supporting an operative member comprising a plurality of splines having a width and a spacing selected to promote expansion of the expandable support member between a collapsed configuration and an expanded configuration, wherein a portion of the support member defines a surface in the expanded configuration; a solid elastomeric body, wherein the expandable support member is disposed on the solid elastomeric body within a perimeter of the solid elastomeric body; and the operative member coupled with the solid elastomeric body.
 11. The system of claim 10, wherein the plurality of splines comprise: a central axis spline; a first subset of splines extending away from the central axis in a first direction; and a second subset of splines extending away from the central axis spline in a direction opposite the first direction.
 12. The system of claim 11, wherein the first subset of splines is arranged in parallel to one another and the second subset of splines is arranged in parallel to one another.
 13. The system of claim 12, wherein the first subset of splines and the second subset of splines extend away from the central axis spline at an angle such that the first and second subsets of splines extend from the central axis spline towards a distal end of the central axis spline.
 14. The system of claim 13, wherein the first subset of splines and the second subset of splines extend away from the central axis spline at an angle of about 45 degrees.
 15. The system of claim 10, wherein the operative member is coupled with the solid elastomeric body with an elastomeric adhesive.
 16. The system of claim 10, wherein the operative member is a flexible circuit.
 17. The system of claim 16, wherein the flexible circuit comprises a plurality of electrodes patterned to mirror the plurality of splines.
 18. The system of claim 10, wherein the operative member extends across an entire width of the solid elastomeric body.
 19. A method of delivering an expandable support device to a target treatment area comprising: providing the expandable support device configured for delivery through a working channel to the target treatment area, the device comprising: an expandable support member configured for supporting an operative member comprising a plurality of splines having a width and a spacing selected to promote expansion of the expandable support member between a collapsed configuration and an expanded configuration, wherein a portion of the expandable support member defines a surface in the expanded configuration; inserting the expandable support device into a first end of the working channel; and moving the expandable support device through the working channel until the expandable support device passes out of a second end of the working channel.
 20. The method of claim 19, further comprising: positioning the expandable support device into a collapsed position prior to inserting the expandable support device into the working channel. 